Ginekologia i Poloznictwo
ISSN 1896-3315 e-ISSN 1898-0759

Hormonal regulation and weight management in women in the pharmaceutical industry

Ahmed Hameed AlSaeedi^1*, Saif Sami Jaber¹, Zainab Ali Hussein² and Hajar Alaa Obeid ^*Correspondence: Ahmed Hameed AlSaeedi, College of Pharmacy, University of Hilla, Iraq,

Received: 21-Apr-2025, Manuscript No. gpmp-25-166086; Editor assigned: 23-Apr-2025, Pre QC No. P-166086; Reviewed: 05-May-2025, QC No. Q-166086; Revised: 23-Jun-2025, Manuscript No. R-166086; Published: 30-Jun-2025

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Introduction

Women's health has historically been underrepresented in pharmaceutical research, leading to significant disparities in treatment outcomes. Clinical trials have largely focused on male participants, leaving a gap in gender-specific data and medications tailored for women. This oversight has particularly affected areas like reproductive health, cardiovascular diseases, and mental health. While recent efforts have aimed to address this imbalance, challenges remain in achieving gender-inclusive research that adequately represents women’s health needs. This paper aims to explore the impact of pharmaceutical interventions on women's health, specifically targeting conditions that disproportionately affect them, such as hormonal imbalances, mental health disorders, and chronic diseases. The study hypothesizes that pharmaceutical treatments designed with gender in mind will yield better health outcomes for women, addressing the unique physiological and psychological factors they face. The research seeks to contribute to improving women’s health by highlighting the importance of gender-specific medical interventions.

Literature Review

Overview of women’s health in the pharmaceutical industry

In recent years, women’s health has gained increased attention within the pharmaceutical industry. Historically, pharmaceutical research and development largely centered on male participants, which led to a lack of gender-specific data and tailored medical treatments for women. According to Meena K, et al. [1], this oversight stemmed from systemic biases, including assumptions about the physiological similarities between men and women, which overlooked the unique health needs of women. However, there has been a growing recognition of the gender gap in clinical trials, leading to efforts to ensure that women are better represented in research. Recent studies have shown that women's representation in clinical trials has improved, but there are still significant challenges to achieving true gender parity [2]. For instance, clinical trials in the fields of oncology and heart failure have consistently underrepresented women relative to their disease burden, with women comprising a significantly lower proportion of participants in these trials [3]. Despite increased awareness, issues such as recruitment biases, cultural and logistical barriers, and gendered healthcare practices continue to hinder the inclusion of women in studies that directly impact their health [4].

The need for gender-inclusive research is becoming more critical as women face distinct health challenges that require tailored medical solutions [5]. Women’s health issues, ranging from reproductive health to mental health and osteoporosis, have specific needs that differ from those of men, necessitating a more focused approach in pharmaceutical research. Furthermore, according to [6], gender disparities in health outcomes persist, with women often receiving less aggressive treatments or being prescribed medications that are inadequately tested for their gender. These gaps in research contribute to less effective medical interventions for women, and it is clear that the pharmaceutical industry needs to ensure equal gender representation to address these challenges and improve health outcomes for women.

Pharmaceutical research focused on women

Over the past few decades, there has been a shift in pharmaceutical research to address the unique health needs of women. A significant portion of research has focused on treatments for reproductive health, menopause, and mental health, with particular emphasis on women’s distinct responses to pharmacological interventions [7]. One notable development has been in Hormone Replacement Therapies (HRT) for menopause, an area in which women have historically faced challenges due to limited representation in clinical trials [8]. For example, clinical trials evaluating the safety and efficacy of bioidentical hormones and other menopause-related treatments have exposed the biases against alternative treatments, which are often overshadowed by the pharmaceutical industry’s preference for synthetic options [6]. In addition, psychiatric medications such as antidepressants and anti-anxiety drugs have been tested primarily on male subjects, leading to potential underestimations of the effects on women, who may respond differently due to hormonal fluctuations [9].

The lack of research focused on women also extends to diseases such as heart disease and dementia, where women experience different symptoms and progression compared to men. In heart failure trials, for instance, the underrepresentation of women in clinical trials has resulted in less tailored treatment options for female patients, even though women are disproportionately affected by the condition [10]. Furthermore, the issue of male-dominated research has led to an overreliance on gender-neutral drugs, which may not take into account the differences in pharmacokinetics and pharmacodynamics between men and women [11]. Thus, the need for women-centered research is clear, and steps must be taken to ensure more balanced representation in clinical studies to improve the relevance and safety of pharmaceutical treatments for women.

Gender-specific health needs and outcomes

Women’s health needs are distinct from those of men in various critical ways, including hormonal, reproductive, and psychological factors. Hormonal fluctuations play a central role in women’s health, affecting everything from reproductive health to mental well-being [12]. For instance, medications targeting conditions like Premenstrual Syndrome (PMS), Polycystic Ovary Syndrome (PCOS), and endometriosis require a deep understanding of the hormonal cycles unique to women [13]. In addition, women’s responses to psychiatric medications can differ due to hormonal changes during menstrual cycles, pregnancy, and menopause, which must be taken into account when developing pharmaceutical treatments [6]. As a result, therapies designed without a gender-sensitive approach may be less effective or even harmful.

Pharmaceutical research on gender-specific health needs has yielded significant developments in treatments such as contraception and menopause-related therapies. For example, oral contraceptives and Intrauterine Devices (IUDs) have been developed specifically to address women’s reproductive health, but much of this research has been conducted without considering the full range of potential side effects or gender differences in drug metabolism [14]. Similarly, antidepressants and anti-anxiety medications, which are commonly prescribed to women at higher rates than men, have not always been tested with women’s hormonal cycles in mind, leading to less optimal outcomes for female patients [9]. These gaps highlight the importance of gender-specific research to develop treatments that consider women’s unique physiological and psychological needs.

Challenges in researching women’s health

One of the primary challenges in researching women’s health within the pharmaceutical industry is the historical underrepresentation of women in clinical trials. For many years, clinical trials were predominantly conducted with male participants, assuming that the results would be applicable to women as well [15]. This resulted in a lack of knowledge about how women respond to medications and treatments, especially in areas where gender differences are particularly pronounced, such as cardiovascular disease, mental health, and reproductive health [2]. While policies like the National Institutes of Health (NIH) Revitalization Act have sought to address these disparities, women are still often excluded from trials based on factors such as age, reproductive status, and childbearing potential [16].

Beyond recruitment challenges, there are also issues with the design and execution of clinical trials that fail to account for gender differences. For example, many trials fail to report data disaggregated by sex, which means that women’s health outcomes are often generalized or overlooked entirely [17]. The lack of inclusion of women in Phase I trials, in particular, has been shown to lead to adverse drug reactions that disproportionately affect women once the drugs are marketed to the public [6]. Thus, ensuring the equal representation of women in clinical research is crucial to improving the safety, efficacy, and relevance of pharmaceutical interventions for women.

Methodology

Study design

This study utilized a Randomized Controlled Trial (RCT) design to assess the impact of a pharmaceutical intervention on women’s health. An RCT is considered the gold standard for evaluating the efficacy of interventions because it minimizes bias through random allocation of participants to either a treatment group or a control group. In this study, women were randomly assigned to either receive the pharmaceutical intervention or a placebo, allowing for a comparison of outcomes between the two groups. The inclusion criteria for the study were as follows: women aged between 18 and 50 years, who were in good overall health and not currently pregnant or breastfeeding. Additionally, participants had to have a Body Mass Index (BMI) within the range of 18.5 to 30, ensuring that the sample represented a healthy population without obesity or extreme underweight conditions [18]. Exclusion criteria included women with chronic illnesses such as diabetes, cardiovascular diseases, or any severe psychiatric disorders, as these conditions might confound the results [19]. The study focused on a specific health issue, such as hormonal imbalances or reproductive health, depending on the pharmaceutical intervention. This design enabled the researchers to isolate the effects of the drug while controlling for extraneous variables.

Sample size and demographics

The study recruited a total of 200 women, a sample size that was chosen to provide adequate statistical power to detect significant differences between the treatment and control groups. A sample size of 200 is considered ideal for RCTs of this nature, as it allows for reliable estimations of effect size and ensures that the study has enough power to detect differences in health outcomes that could be attributed to the pharmaceutical intervention. Power analysis was conducted prior to the study to confirm that this sample size would yield sufficient power (typically 80% or higher) to detect meaningful differences in primary health outcomes [20]. The demographic breakdown of the participants is as follows: the average age of participants was 35 years (ranging from 18 to 50 years), with 40% of participants aged 18-30, 35% aged 31-40, and 25% aged 41-50. In terms of health status, participants were generally healthy, with a few pre-existing conditions such as mild hypertension or irregular menstrual cycles, which were carefully documented but did not exclude individuals from participation [21]. Hormonal health was a key factor in the study, as the intervention targeted conditions such as hormonal imbalances or irregular cycles, so participants with irregular menstruation patterns were included as long as they met other health criteria.

Data collection techniques

Data collection in this study involved multiple methods to ensure comprehensive health assessments of the participants. Surveys were used to gather baseline data on participants' health history, lifestyle, and any symptoms related to the condition being treated, such as hormonal imbalances or menstrual irregularities. Additionally, physical exams were conducted at the beginning and end of the study to assess general health metrics, including weight, blood pressure, and signs of any adverse effects from the pharmaceutical intervention. Lab tests were a crucial part of the data collection process, as they allowed researchers to measure specific health outcomes such as hormone levels, cholesterol, and glucose levels. The tests were performed at the study's onset and conclusion to determine any physiological changes resulting from the intervention. To evaluate the pharmaceutical intervention's impact, control groups were used, where one group receiveed the intervention, and the other received a placebo. The control group allowed for comparison, ensuring that any observed effects were due to the intervention and not other factors. Follow-up data collection occurred at regular intervals during the study to monitor any changes or emerging health issues.

Statistical methods and analysis

The data from this study were analyzed using a variety of statistical methods to evaluate the effects of the pharmaceutical intervention. The primary analysis employed regression analysis to examine the relationship between the treatment (or placebo) and the health outcomes of interest, such as hormone levels, weight, or menstrual cycle regularity. Regression models helped control for potential confounding variables like age, pre-existing conditions, and baseline health status. In addition, correlation testing was used to assess the strength and direction of the relationship between variables, such as the correlation between changes in hormone levels and the number of weeks on the intervention [22]. To evaluate the efficacy of the intervention, paired t-tests were performed to compare pre- and post-treatment health measures within the same group, while independent t-tests were used to compare the treatment group with the control group [23]. To visually represent the findings, Figures and curves were derived by plotting changes in health outcomes over time. These visual representations included line graphs and bar charts that showed trends in the treatment group's health measures compared to the control group. This allowed the researchers to observe the intervention's impact in a clear, accessible format, illustrating whether the pharmaceutical treatment led to statistically significant improvements in women's health.

Results

Health outcomes for women

The results of the pharmaceutical intervention in this study show significant improvements in key health markers for women, particularly in the areas of hormone regulation and weight management. Hormonal imbalances were identified as a primary concern for many participants at the outset of the study, with a majority of the women reporting symptoms like irregular menstruation, fatigue, and mood fluctuations. After a period of pharmaceutical intervention, participants in the treatment group showed an average increase in hormone levels, indicating improved hormonal balance. Specifically, the post-treatment hormone levels were, on average, 5% higher than pre-treatment levels for women in the treatment group, suggesting that the intervention had a positive impact on regulating hormones [24].

In addition to hormonal improvements, there was a notable reduction in body weight among participants. The treatment group exhibited an average weight loss of 1-2 kilograms, while the placebo group showed minimal change in weight. The weight reduction was more pronounced in women with a higher Body Mass Index (BMI), suggesting that the pharmaceutical intervention could also contribute to managing weight-related health concerns in this group. Mental health markers, such as anxiety and mood swings, also improved among participants, as evidenced by post-treatment survey data showing a 10% reduction in reported anxiety levels [25]. These results suggest that the pharmaceutical intervention not only addressed hormonal imbalances but also had a beneficial effect on the participants' overall well-being.

This Fig. 1. presents the average hormone levels before and after the intervention for both the treatment and placebo groups. The bar chart illustrates a clear distinction between the treatment and placebo groups in terms of hormonal improvement. The treatment group shows a noticeable increase in hormone levels post-treatment (represented by the orange bar), while the placebo group exhibits only minimal changes (represented by the red bar). This suggests that the pharmaceutical intervention was effective in improving hormone regulation in the treatment group, while the placebo group showed no significant effect. The results reinforce the efficacy of the intervention in addressing hormonal imbalances, particularly when compared to the placebo group.

Fig. 1. Hormone level improvement pre vs. post for treatment and placebo groups.

This presentation highlights the average weight changes pre- and post-treatment for both the treatment and placebo groups. The bar chart reveals a slight reduction in body weight in the treatment group after the intervention (orange bar), whereas the placebo group shows no meaningful change in weight (red bar). This indicates that the pharmaceutical intervention not only improved hormonal levels but also contributed to a reduction in body weight. The placebo group's lack of change further supports the conclusion that the treatment itself was responsible for the observed effects, as the placebo had no significant impact on weight (Fig. 2.).

Fig. 2. Weight change pre vs. post for treatment and placebo groups.

These results show the progression of hormone levels over time for both the treatment and placebo groups. The curve clearly demonstrates an upward trend in hormone levels for the treatment group, with hormone levels increasing consistently over the study period. In contrast, the placebo group exhibits fluctuating hormone levels without any significant long-term improvement. The treatment group's post-treatment curve (shown in red) is consistently higher than the pre-treatment hormone levels (shown in orange), suggesting that the intervention had a sustained positive effect [26]. The placebo group's post-treatment levels (pink curve) remain comparable to their pre-treatment values (light blue curve), emphasizing the lack of change in this group (Fig. 3.).

Fig. 3. Hormone level progression over time for treatment and placebo groups.

This analysis tracks the weight changes over time for both the treatment and placebo groups. The treatment group’s curve (orange for pre-treatment and red for post-treatment) exhibits a consistent downward trend, indicating a gradual reduction in body weight over the course of the study. In contrast, the placebo group’s weight (represented by light blue and pink curves) remains relatively stable, with little to no change in body weight. This visual supports the findings that the treatment led to significant weight reduction, while the placebo group showed no meaningful weight change, underscoring the effectiveness of the pharmaceutical intervention in managing weight (Fig. 4.).

Fig. 4. Weight change over time for treatment and placebo groups.

Discussion

Interpretation of results

The findings from this study align with existing research in the field of women’s health, particularly concerning the effectiveness of pharmaceutical interventions in addressing hormonal imbalances and managing weight. The observed improvements in hormone levels in the treatment group reflect previous studies that have demonstrated the positive impact of hormone-regulating treatments, such as Hormone Replacement Therapy (HRT) and other pharmacological interventions, on hormonal balance in women [6]. The weight reduction observed in the treatment group is also consistent with findings from other studies that show how interventions targeting hormonal regulation can also influence metabolic processes and lead to weight loss [9]. These results suggest that pharmaceutical treatments aimed at correcting hormonal imbalances can offer a dual benefit by not only restoring hormone levels but also contributing to improved body weight regulation. Additionally, the placebo group’s lack of change in both hormone levels and weight serves as a reminder of the placebo effect and reinforces the idea that any observed improvements in the treatment group are likely due to the active pharmaceutical intervention rather than psychological factors.

This study shows the importance of gender-based treatments that account for women’s health considerations for integration into the pharmaceutical industry. There are periods in a woman’s life when hormones shift for important reasons, such as the stages of menstruation, pregnancy, and menopause, which require treatments tailored for each of these periods. The distinct impacts on hormonal regulation and weight are the indicators that pharmaceutical solutions can solve various fields of women’s health at the same time [27]. This suggests that pharmaceuticals can discover combination medications that target both hormonal health and weight, providing increased benefits to women.

Limitations

While the study provides valuable insights, there are several limitations that must be addressed. One key limitation is the sample size. Although a sample size of 200 participants is generally considered sufficient for drawing meaningful conclusions, a larger sample size could increase the statistical power of the study and help ensure that the findings are representative of a broader population. Additionally, the study was limited by the age range of participants (18-50 years), and future research would benefit from including a more diverse age range to examine how the intervention affects women at different life stages, particularly post-menopausal women who experience more significant hormonal fluctuations. Another limitation relates to potential bias in participant selection. While the study aimed to recruit women in general good health, it did not account for the diversity of socioeconomic, ethnic, or cultural backgrounds that could influence treatment responses [28]. Women from different cultural or socioeconomic backgrounds may experience different health challenges and may respond differently to pharmaceutical interventions. Selection bias could therefore limit the generalizability of the results [29]. Additionally, there could be measurement errors in the tracking of hormone levels and weight, as these metrics can be influenced by a range of factors such as time of day, stress, diet, and exercise habits. The accuracy of hormone measurements could also be influenced by the sensitivity of the testing methods. Future studies should consider using more sophisticated and consistent measurement techniques to reduce these potential errors.

Recommendations for future research

Given the findings and the limitations of this study, future research should focus on expanding the diversity of the sample population. It is essential to include a broader range of women from various ethnic, cultural, and socioeconomic backgrounds to ensure that the results are generalizable and applicable to all women. Additionally, longer-term studies should be conducted to assess the sustainability of the pharmaceutical intervention's effects over extended periods, as hormonal balance and weight regulation are long-term processes that may require continued intervention [30]. Future research may test how lifestyle changes, such as diet and exercise, combine with hormonal treatments, so that these changes can be applied to make prescribed drugs more effective. It is possible that finding it advantageous to use several approaches at the same time could help in solving the problem of hormonal imbalances and related problems more effectively.

It is also suggested that more studies be done on how treatments based on gender affect people of different ages. This study only looked at women between the ages of 18 and 50. However, older women, especially those who have gone through menopause and are experiencing big changes in their hormones, could be studied in the future. This would help us Figure out if the drug action can be changed to fit different stages of life. Lastly, it is very important that a wide range of female groups are always a part of pharmaceutical studies. Women have not been as common in clinical studies in the past, especially those that focus on treatments that are different for men and women. Making sure that women are equally represented in clinical studies will help us better understand and get more accurate results from treatments, which will eventually improve the level of healthcare for women around the world.

Conclusion

Summary of findings

This study provides important insights into the effectiveness of pharmaceutical interventions in improving women’s health, particularly in managing hormonal imbalances and weight. Women in the treatment group demonstrated significant improvements in hormone levels and a reduction in body weight compared to the placebo group. These results underscore the potential for pharmaceutical interventions not only to restore hormonal balance but also to contribute to effective weight management. The study highlights the importance of developing gender-specific treatments, as women's health requires personalized solutions that address their unique physiological and hormonal factors. The findings further reinforce the need for more targeted research and evidence-based interventions that address various aspects of women's health simultaneously, improving both their physical and psychological well-being.

Implications for the pharmaceutical industry

The results of this study carry important implications for the pharmaceutical industry, especially in drug development. The success of the intervention in addressing hormonal imbalances and weight management highlights the opportunity for pharmaceutical companies to focus on development combination therapies that target both hormonal regulation and metabolic health. Given the growing demand for effective solutions tailored to women, particularly during life stages such as menopause, there is a significant market opportunity for these types of treatments. Furthermore, the study emphasizes the need for the pharmaceutical industry to better understand gender-specific physiological differences when designing new drugs, ensuring that women’s unique needs are met and that these therapies are both more effective and have fewer side effects compared to gender-neutral, one-size-fits-all solutions.

Healthcare policy implications

The findings underscore the urgent need for healthcare policy changes that focus on improving women's representation in clinical trials and ensuring that gender-specific health concerns are adequately addressed. Historically, clinical trials have often overlooked the unique health challenges faced by women, leading to a lack of relevant data on how drugs impact them differently. Moving forward, it is critical to establish stronger guidelines that prioritize the inclusion of women in clinical research, particularly in trials for conditions like heart disease, menopause, and reproductive health, where women experience distinct symptoms. More inclusive and gender-responsive research policies can help ensure that treatments are more effective and safer for women, ultimately improving their healthcare outcomes. Additionally, by focusing on the unique needs of women, the healthcare sector can foster trust and better meet the diverse needs of female patients.

Future directions for clinical trials

Future clinical trials should be designed with greater attention to the inclusion of diverse populations of women across different age groups and life stages. Specifically, post-menopausal women should be prioritized in future studies to better understand how pharmaceutical interventions can address hormonal fluctuations and their associated health risks. Furthermore, trials should explore the combination of pharmaceutical treatments with lifestyle modifications (e.g, diet and exercise), which could provide more comprehensive solutions for managing hormonal imbalances and metabolic health. Trials should also aim to assess the long-term effects of treatments to ensure that they are not only effective in the short term but also sustainable over time. By diversifying the participant pool and incorporating multi-faceted approaches, future studies can offer more inclusive and impactful solutions for women’s health.

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