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Last Updated: April 30, 2025

CLINICAL TRIALS PROFILE FOR ESTRADIOL AND PROGESTERONE


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505(b)(2) Clinical Trials for Estradiol And Progesterone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT05899010 ↗ MIcronized PROgesterone in Frozen Embryo Transfer Cycles Not yet recruiting Fundación Santiago Dexeus Font Phase 3 2023-06-01 This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Estradiol And Progesterone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000897 ↗ A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00001259 ↗ A Treatment Study for Premenstrual Syndrome (PMS) Completed National Institute of Mental Health (NIMH) Phase 1 1992-08-11 This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00001322 ↗ The Effects of Reproductive Hormones on Mood and Behavior Completed National Institute of Mental Health (NIMH) N/A 1994-06-09 This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00001481 ↗ The Role of Hormones in Postpartum Mood Disorders Recruiting National Institute of Mental Health (NIMH) Phase 2 1996-04-26 Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone. The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major effective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month. Outcome measures will include mood, behavioral and hormonal parameters (a separate protocol done in collaboration with NICHD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Estradiol And Progesterone

Condition Name

Condition Name for Estradiol And Progesterone
Intervention Trials
Infertility 58
Menopause 17
Breast Cancer 12
Contraception 12
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Condition MeSH

Condition MeSH for Estradiol And Progesterone
Intervention Trials
Infertility 72
Breast Neoplasms 27
Polycystic Ovary Syndrome 13
Disease 9
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Clinical Trial Locations for Estradiol And Progesterone

Trials by Country

Trials by Country for Estradiol And Progesterone
Location Trials
United States 226
Egypt 33
Brazil 9
Spain 7
Vietnam 6
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Trials by US State

Trials by US State for Estradiol And Progesterone
Location Trials
California 18
Illinois 17
Virginia 15
North Carolina 13
New York 13
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Clinical Trial Progress for Estradiol And Progesterone

Clinical Trial Phase

Clinical Trial Phase for Estradiol And Progesterone
Clinical Trial Phase Trials
Phase 4 65
Phase 3 36
Phase 2/Phase 3 8
[disabled in preview] 55
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Clinical Trial Status

Clinical Trial Status for Estradiol And Progesterone
Clinical Trial Phase Trials
Completed 118
Recruiting 48
Unknown status 34
[disabled in preview] 22
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Clinical Trial Sponsors for Estradiol And Progesterone

Sponsor Name

Sponsor Name for Estradiol And Progesterone
Sponsor Trials
National Cancer Institute (NCI) 19
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 15
Cairo University 11
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Sponsor Type

Sponsor Type for Estradiol And Progesterone
Sponsor Trials
Other 313
NIH 62
Industry 49
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Estradiol and Progesterone: Clinical Trials, Market Analysis, and Projections

Introduction

Estradiol and progesterone are hormones that play crucial roles in various physiological processes, particularly in women's health. These hormones are widely used in hormone replacement therapy (HRT), contraception, and the treatment of several medical conditions. Here, we will delve into the current state of clinical trials, market analysis, and future projections for these hormones.

Clinical Trials Update

Hormone Replacement Therapy (HRT) for Postmenopausal Women

A significant clinical trial involving estradiol and progesterone is the randomized, blinded, placebo-controlled secondary prevention trial for postmenopausal women with established coronary heart disease. This study, which included 2763 women, aimed to determine if estrogen plus progestin therapy alters the risk for coronary heart disease (CHD) events. The results showed no overall effect on CHD events, despite improvements in lipid profiles. However, there was a higher incidence of venous thromboembolic events and gallbladder disease in the hormone group compared to the placebo group[1].

Breast Cancer Treatment

In the context of breast cancer, hormone therapy involving estradiol and progesterone is being explored. For instance, a Phase II trial is investigating the use of estradiol in treating patients with estrogen receptor beta (ER beta) positive, triple negative breast cancer. This study aims to determine how well estradiol works in this specific type of breast cancer, where ER beta is overexpressed[4].

Other Clinical Applications

Other clinical trials are focusing on the combination of estradiol and progesterone in various therapeutic settings. For example, the use of body-identical hormone replacement therapy (HRT) like BIJUVE (1mg Estradiol/100mg Progesterone) has been approved for estrogen insufficiency traits in postmenopausal women, highlighting the ongoing research and development in this area[3].

Market Analysis

Current Market Size and Growth

The market for estradiol and progesterone is experiencing significant growth driven by several factors. The US progesterone market, for instance, was valued at around $486.8 million in 2022 and is projected to reach $1.138 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 11.2% during the forecast period[2].

On a global scale, the progesterone market is expected to grow from $1.50 billion in 2024 to $4.80 billion by 2034, with a CAGR of 12.3%. This growth is fueled by the increasing prevalence of conditions such as breast cancer, AIDS, and amenorrhea, as well as the rising demand for hormone therapy in postmenopausal women[3].

Market Drivers

Several factors are driving the growth of the estradiol and progesterone market:

  • Increasing Prevalence of Breast Cancer and Other Conditions: The rising cases of breast cancer, AIDS, and other health issues are driving the demand for hormone therapy.
  • Growing Geriatric Population: The increasing number of postmenopausal women contributes to the demand for HRT.
  • Advancements in Drug Delivery Systems: Technical developments in drug delivery systems are enhancing the efficacy and safety of hormone therapies.
  • Increased Patient Awareness: Greater awareness among women about their health and the benefits of hormone therapy is also a significant driver[2][3].

Regional Outlook

The market for estradiol and progesterone is geographically diverse, with North America, Europe, and Asia-Pacific regions showing significant growth. North America is expected to garner a considerable share due to the high disease burden and the foresighted approach of progesterone vendors in strengthening their research and development capabilities[3].

Competitive Landscape

The market is highly competitive, with key players such as Merck & Co., Inc., Pfizer Inc., Bayer AG, AbbVie Inc., and Johnson & Johnson. These companies are adopting novel technologies, expanding their research and development, and forming strategic partnerships to augment their market share[2][5].

Projections and Future Trends

Market Growth Projections

The global estradiol and progesterone market is projected to continue its upward trajectory. The US progesterone market, for example, is expected to grow at a CAGR of 12.6% from 2024 to 2034. Similar growth rates are anticipated in other regions, such as the United Kingdom (13.7% CAGR), China (13.2% CAGR), Japan (14.1% CAGR), and South Korea (14.7% CAGR)[3].

Emerging Trends

Several trends are expected to shape the future of the estradiol and progesterone market:

  • Personalized Medicine: There is a growing focus on personalized medicine, with hormone therapies being tailored to individual patient needs.
  • Advancements in Drug Delivery: Continued innovations in drug delivery systems will improve the efficacy and safety of hormone therapies.
  • Increased Focus on Women's Health: Greater emphasis on women's health and the development of pharmaceuticals will drive the demand for estradiol and progesterone[3].

Side Effects and Challenges

Despite the growth and potential of estradiol and progesterone, there are challenges associated with their use. Common side effects include weight fluctuations, increased face and body hair, headaches, persistent breast tenderness, and baldness. These side effects can be serious if the treatment is not managed properly[3].

Key Takeaways

  • Clinical Trials: Ongoing clinical trials are exploring the efficacy and safety of estradiol and progesterone in various therapeutic settings, including HRT and breast cancer treatment.
  • Market Growth: The market for estradiol and progesterone is growing significantly, driven by increasing prevalence of health conditions and advancements in drug delivery systems.
  • Regional Outlook: North America, Europe, and Asia-Pacific regions are expected to contribute substantially to the market growth.
  • Competitive Landscape: The market is highly competitive, with key players focusing on research and development and strategic partnerships.
  • Future Trends: Personalized medicine, advancements in drug delivery, and increased focus on women's health are expected to shape the future of the market.

FAQs

What are the primary uses of estradiol and progesterone in clinical settings?

Estradiol and progesterone are primarily used in hormone replacement therapy (HRT) for postmenopausal women, contraception, and the treatment of conditions such as breast cancer and amenorrhea.

What are the key drivers of the estradiol and progesterone market?

The market is driven by the increasing prevalence of breast cancer, AIDS, and other health issues, as well as advancements in drug delivery systems and increased patient awareness.

What are the common side effects associated with estradiol and progesterone therapy?

Common side effects include weight fluctuations, increased face and body hair, headaches, persistent breast tenderness, and baldness.

Which regions are expected to contribute significantly to the market growth?

North America, Europe, and Asia-Pacific regions are expected to contribute substantially to the market growth due to high disease burden and advancements in healthcare.

Who are the key players in the estradiol and progesterone market?

Key players include Merck & Co., Inc., Pfizer Inc., Bayer AG, AbbVie Inc., and Johnson & Johnson, among others.

Sources

  1. Randomized Trial of Estrogen Plus Progestin for Secondary Prevention of Coronary Heart Disease in Postmenopausal Women. JAMA.
  2. US Progesterone Market Report 2022 to 2030. Insights10.
  3. Progesterone Therapy in Demand for Personalized Medicine. PR Newswire.
  4. Hormone Therapy For Breast Cancer Clinical Trials. Mayo Clinic.
  5. Estrogen and Progesterone Market Size, Share, Growth, Analysis. Biospace.

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