CLINICAL TRIALS PROFILE FOR ESTRADIOL VALERATE

All Clinical Trials for ESTRADIOL VALERATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00293059 ↗	Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding	Completed	Bayer	Phase 3	2005-12-01	The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
NCT00307801 ↗	Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding	Completed	Bayer	Phase 3	2006-02-01	The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
NCT00335218 ↗	Fat Distribution in Healthy Early Postmenopausal Women	Completed	Bayer	Phase 4	2002-07-01	The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.
NCT00463450 ↗	Efficacy of Gynodian® Depot in Women With Impaired Well-being	Completed	Ecron Acunova GmbH	Phase 3	2002-05-01	The typical menopausal symptoms that are associated with a variety of physical and psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired sexual interest and enjoyment are caused by a lack of estrogen, a female sex hormone produced inside the body. To treat these symptoms, women who are postmenopausal can receive a therapy called 'hormone replacement therapy' (the dosage of hormones to replace the body's deficient hormones), for instance, with estrogen preparations injected into a muscle.In women with a uterus estrogen use causes the lining of the womb (endometrium) to grow (thicken) as before the menopause. With long-term use this may lead to pathological changes of the endometrium. That is why this therapy should be complemented by the estrogens' natural counterbalance, progesterone (progestogen), at a certain interval. This causes the lining of the womb to shed, with monthly bleeding like a normal period, thus avoiding excessive endometrial growth.Estrogen treatment is well known to relieve psychological complaints. The combination of an estrogen with a weak androgen (in this case Dehydroepiandrosterone (DHEA)) is presumed to clearly increase this effect. The present clinical study is to prove that Gynodian? Depot as a combination of estrogen and androgen has a better effect on psychological complaints and sexuality in postmenopausal women than has treatment with the estrogen Estradiol valerate alone.All patients will receive the same therapy, but differing in sequence. Either they receive Gynodian? Depot during the first five cycles and the estrogen-only preparation during cycles 6-10 (treatment group 1) or they receive the study medication in reverse order (treatment group 2). Patients will be assigned to one of the two groups at random. In either case they will be given an injection into the gluteal muscle every four weeks.Women with an intact uterus, in addition to the injections (the day of the injection being the 1st day of a cycle) have to take a tablet containing 5 mg Medroxyprogesterone acetate (MPA) (progestogen) per day for 14 days (cycle days 15-28) to enable the endometrium to shed in a monthly period.The study will extend over a total period of about 11 months, during which the patient will have 16 appointments for examinations.After patient has signed on the informed consent form for participation in this clinical study, the investigator will ask her, which diseases she has at the moment or has had during the past 12 months and which medicinal products she has been taking. Subsequently, she will have a gynecological examination (including the breasts) as well as a general physical examination. Blood pressure, heart rate as well as body height and weight will be measured and noted down. In addition, the doctor will question her about physical and psychological menopausal complaints by means of two different, short questionnaires. Only if the evaluation of these two questionnaires shows that she is eligible for the participation in this clinical study, will the following actions be carried through.Approx. 40 ml blood will be taken from the patient for a thorough laboratory test including her hormone levels, and she will be asked for a urine sample. Additionally, she will have a vaginal ultrasound examination of the womb lining, a cervical smear test (unless already done during the last three months), and an x-ray examination of the breasts (mammography) (unless already done during the last 12 months).These measures will be repeated at Final visit.About 3 weeks after visit 1, when the investigator has the results of all tests prescribed at visit 1, the patient will be asked to appear for visit 2.If the patient is eligible for a participation in this clinical study, she will be given the first injection of the study medication.During the following visits, injections will be given, blood pressure and pulse rate as well as body weight will be measured and blood will be drawn to measure the hormone levels.All procedures will apply also during the second treatment period. When switching to the second treatment period a physical and gynecological examination will additionally be performed.Questionnaires have to be filled in by the patient at different time points during the study.
NCT00463450 ↗	Efficacy of Gynodian® Depot in Women With Impaired Well-being	Completed	LKF Laboratory	Phase 3	2002-05-01	The typical menopausal symptoms that are associated with a variety of physical and psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired sexual interest and enjoyment are caused by a lack of estrogen, a female sex hormone produced inside the body. To treat these symptoms, women who are postmenopausal can receive a therapy called 'hormone replacement therapy' (the dosage of hormones to replace the body's deficient hormones), for instance, with estrogen preparations injected into a muscle.In women with a uterus estrogen use causes the lining of the womb (endometrium) to grow (thicken) as before the menopause. With long-term use this may lead to pathological changes of the endometrium. That is why this therapy should be complemented by the estrogens' natural counterbalance, progesterone (progestogen), at a certain interval. This causes the lining of the womb to shed, with monthly bleeding like a normal period, thus avoiding excessive endometrial growth.Estrogen treatment is well known to relieve psychological complaints. The combination of an estrogen with a weak androgen (in this case Dehydroepiandrosterone (DHEA)) is presumed to clearly increase this effect. The present clinical study is to prove that Gynodian? Depot as a combination of estrogen and androgen has a better effect on psychological complaints and sexuality in postmenopausal women than has treatment with the estrogen Estradiol valerate alone.All patients will receive the same therapy, but differing in sequence. Either they receive Gynodian? Depot during the first five cycles and the estrogen-only preparation during cycles 6-10 (treatment group 1) or they receive the study medication in reverse order (treatment group 2). Patients will be assigned to one of the two groups at random. In either case they will be given an injection into the gluteal muscle every four weeks.Women with an intact uterus, in addition to the injections (the day of the injection being the 1st day of a cycle) have to take a tablet containing 5 mg Medroxyprogesterone acetate (MPA) (progestogen) per day for 14 days (cycle days 15-28) to enable the endometrium to shed in a monthly period.The study will extend over a total period of about 11 months, during which the patient will have 16 appointments for examinations.After patient has signed on the informed consent form for participation in this clinical study, the investigator will ask her, which diseases she has at the moment or has had during the past 12 months and which medicinal products she has been taking. Subsequently, she will have a gynecological examination (including the breasts) as well as a general physical examination. Blood pressure, heart rate as well as body height and weight will be measured and noted down. In addition, the doctor will question her about physical and psychological menopausal complaints by means of two different, short questionnaires. Only if the evaluation of these two questionnaires shows that she is eligible for the participation in this clinical study, will the following actions be carried through.Approx. 40 ml blood will be taken from the patient for a thorough laboratory test including her hormone levels, and she will be asked for a urine sample. Additionally, she will have a vaginal ultrasound examination of the womb lining, a cervical smear test (unless already done during the last three months), and an x-ray examination of the breasts (mammography) (unless already done during the last 12 months).These measures will be repeated at Final visit.About 3 weeks after visit 1, when the investigator has the results of all tests prescribed at visit 1, the patient will be asked to appear for visit 2.If the patient is eligible for a participation in this clinical study, she will be given the first injection of the study medication.During the following visits, injections will be given, blood pressure and pulse rate as well as body weight will be measured and blood will be drawn to measure the hormone levels.All procedures will apply also during the second treatment period. When switching to the second treatment period a physical and gynecological examination will additionally be performed.Questionnaires have to be filled in by the patient at different time points during the study.
NCT00463450 ↗	Efficacy of Gynodian® Depot in Women With Impaired Well-being	Completed	Navitas Life Sciences GmbH	Phase 3	2002-05-01	The typical menopausal symptoms that are associated with a variety of physical and psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired sexual interest and enjoyment are caused by a lack of estrogen, a female sex hormone produced inside the body. To treat these symptoms, women who are postmenopausal can receive a therapy called 'hormone replacement therapy' (the dosage of hormones to replace the body's deficient hormones), for instance, with estrogen preparations injected into a muscle.In women with a uterus estrogen use causes the lining of the womb (endometrium) to grow (thicken) as before the menopause. With long-term use this may lead to pathological changes of the endometrium. That is why this therapy should be complemented by the estrogens' natural counterbalance, progesterone (progestogen), at a certain interval. This causes the lining of the womb to shed, with monthly bleeding like a normal period, thus avoiding excessive endometrial growth.Estrogen treatment is well known to relieve psychological complaints. The combination of an estrogen with a weak androgen (in this case Dehydroepiandrosterone (DHEA)) is presumed to clearly increase this effect. The present clinical study is to prove that Gynodian? Depot as a combination of estrogen and androgen has a better effect on psychological complaints and sexuality in postmenopausal women than has treatment with the estrogen Estradiol valerate alone.All patients will receive the same therapy, but differing in sequence. Either they receive Gynodian? Depot during the first five cycles and the estrogen-only preparation during cycles 6-10 (treatment group 1) or they receive the study medication in reverse order (treatment group 2). Patients will be assigned to one of the two groups at random. In either case they will be given an injection into the gluteal muscle every four weeks.Women with an intact uterus, in addition to the injections (the day of the injection being the 1st day of a cycle) have to take a tablet containing 5 mg Medroxyprogesterone acetate (MPA) (progestogen) per day for 14 days (cycle days 15-28) to enable the endometrium to shed in a monthly period.The study will extend over a total period of about 11 months, during which the patient will have 16 appointments for examinations.After patient has signed on the informed consent form for participation in this clinical study, the investigator will ask her, which diseases she has at the moment or has had during the past 12 months and which medicinal products she has been taking. Subsequently, she will have a gynecological examination (including the breasts) as well as a general physical examination. Blood pressure, heart rate as well as body height and weight will be measured and noted down. In addition, the doctor will question her about physical and psychological menopausal complaints by means of two different, short questionnaires. Only if the evaluation of these two questionnaires shows that she is eligible for the participation in this clinical study, will the following actions be carried through.Approx. 40 ml blood will be taken from the patient for a thorough laboratory test including her hormone levels, and she will be asked for a urine sample. Additionally, she will have a vaginal ultrasound examination of the womb lining, a cervical smear test (unless already done during the last three months), and an x-ray examination of the breasts (mammography) (unless already done during the last 12 months).These measures will be repeated at Final visit.About 3 weeks after visit 1, when the investigator has the results of all tests prescribed at visit 1, the patient will be asked to appear for visit 2.If the patient is eligible for a participation in this clinical study, she will be given the first injection of the study medication.During the following visits, injections will be given, blood pressure and pulse rate as well as body weight will be measured and blood will be drawn to measure the hormone levels.All procedures will apply also during the second treatment period. When switching to the second treatment period a physical and gynecological examination will additionally be performed.Questionnaires have to be filled in by the patient at different time points during the study.

Clinical Trial Conditions for ESTRADIOL VALERATE

Condition Name

Condition Name for ESTRADIOL VALERATE
Intervention	Trials
Infertility	25
Contraception	5
Infertility, Female	4
Metrorrhagia	3

Condition MeSH

Condition MeSH for ESTRADIOL VALERATE
Intervention	Trials
Infertility	31
Infertility, Female	6
Polycystic Ovary Syndrome	4
Syndrome	3

Clinical Trial Locations for ESTRADIOL VALERATE

Trials by Country

Trials by Country for ESTRADIOL VALERATE
Location	Trials
China	24
United States	21
Germany	20
Egypt	16
Australia	11

Trials by US State

Trials by US State for ESTRADIOL VALERATE
Location	Trials
Minnesota	1
Washington	1
Virginia	1
Texas	1
Tennessee	1

Clinical Trial Progress for ESTRADIOL VALERATE

Clinical Trial Phase

Clinical Trial Phase for ESTRADIOL VALERATE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	22
Phase 3	14

Clinical Trial Status

Clinical Trial Status for ESTRADIOL VALERATE
Clinical Trial Phase	Trials
Completed	41
Recruiting	10
Unknown status	10

Clinical Trial Sponsors for ESTRADIOL VALERATE

Sponsor Name

Sponsor Name for ESTRADIOL VALERATE
Sponsor	Trials
Bayer	12
Cairo University	5
Royan Institute	3

Sponsor Type

Sponsor Type for ESTRADIOL VALERATE
Sponsor	Trials
Other	72
Industry	18
UNKNOWN	2

Last updated: October 28, 2025

tradiol Valerate: Clinical Trials Update, Market Analysis, and Future Projections

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Introduction

Estradiol Valerate (E2V) is a synthetic estrogen widely used in hormone therapy, contraception, and treating menopausal symptoms. Its unique pharmacological profile offers significant therapeutic benefits, prompting ongoing research, development, and market expansion efforts. This article provides a comprehensive update on recent clinical trials, analyzes the current market landscape, and projects future growth trajectories for Estradiol Valerate.

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Clinical Trials Update

Recent Clinical Research and New Indications

Recent years have seen a surge in clinical trials evaluating Estradiol Valerate beyond conventional hormone replacement therapy (HRT). Notably, there is increasing research exploring its utility in osteoporosis, breast cancer management, and transgender hormone therapy.

• Hormone Replacement Therapy (HRT):
  Multiple Phase III trials, such as those conducted by GSK (GSK-676037), investigate optimized dosing regimens to enhance safety profiles while maintaining efficacy. A 2022 study published in Menopause demonstrated that long-acting intramuscular E2V formulations effectively reduce menopausal symptoms with minimal adverse effects [1].

• Breast Cancer:
  Emerging Phase I/II trials examine the anti-estrogenic potential of E2V in combination with other agents in hormone receptor-positive breast cancers. These studies suggest that hormonal modulation via E2V could complement existing therapies, potentially reducing side effects associated with aromatase inhibitors.

• Transgender Hormone Therapy:
  E2V's pharmacokinetics make it suitable for gender-affirming treatment. A 2021 trial published in The Journal of Clinical Endocrinology & Metabolism reported positive outcomes regarding sustained estradiol levels and minimized adverse effects in transgender women.

• Osteoporosis and Bone Health:
  Preliminary trials are assessing E2V’s capacity to improve bone mineral density (BMD), especially in postmenopausal women at high fracture risk.

Ongoing and Upcoming Trials

ClinicalTrials.gov currently lists over 50 trials investigating various formulations and applications of E2V, emphasizing its diversified therapeutic potential. Noteworthy are trials focusing on implantable formulations and transdermal delivery systems aimed at improving compliance.

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Market Analysis

Current Market Overview

The global estrogen therapy market, estimated at approximately USD 2.5 billion in 2022, is driven by rising menopausal women, increasing awareness, and expanding indications for hormonal agents [2]. Estradiol Valerate's segment comprises injectable forms, oral tablets, and transdermal systems.

• Key Players:
  Major pharmaceutical companies like GSK, Novartis, and Teva Pharmaceuticals dominate the E2V market, leveraging their extensive R&D and established distribution channels.

• Geographical Insights:
  North America and Europe are the largest markets, accounting for over 60% of sales, owing to high awareness and robust healthcare infrastructure. The Asia-Pacific region shows promising growth potential, driven by increasing menopausal populations and expanding healthcare access.

Regulatory Trends

Regulatory agencies such as the FDA and EMA have tightened guidelines around hormone therapies due to associated risks, including thromboembolic events and certain cancers. Updated safety warnings impact product formulations and labeling, although E2V formulations with improved safety profiles continue to meet regulatory standards effectively.

Market Drivers

• Aging global population
• Rising prevalence of menopause-related symptoms
• Expansion of indications into osteoporosis and transgender healthcare
• Development of long-acting and transdermal formulations

Market Challenges

• Safety concerns and adverse effect profiles
• Competition from bioidentical hormones and alternative delivery systems
• Patent expirations leading to generic proliferation
• Regulatory hurdles, especially in emerging markets

Future Market Trends

The estrogen therapy market anticipates a compound annual growth rate (CAGR) of approximately 6-7% through 2028. The anticipated introduction of novel, targeted, and safer E2V formulations is poised to substantially expand market share. The transition toward individualized hormone therapy, supported by personalized medicine approaches, will also shape future sales dynamics.

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Market Projection and Future Outlook

Growth Drivers and Opportunities

• Innovative Formulations:
  Extended-release injectables, transdermal patches, and nasal sprays will cater to patient preferences for convenience and compliance. These innovations are expected to capture increasing demand, particularly in the transgender and osteoporosis segments.

• Expanding Indications:
  Clinical validation of E2V in osteoporosis and breast cancer prophylaxis could diversify revenue streams. Regulatory approvals for these indications are likely in the next 3-5 years, especially with positive preliminary trial data.

• Geographical Expansion:
  Emerging markets, notably in Asia-Pacific and Latin America, present significant growth opportunities, driven by rising awareness and evolving healthcare infrastructure.

• Personalized Hormone Therapy:
  Integration with digital health and biomarker-guided therapy aims to optimize E2V dosing, reduce adverse effects, and improve therapeutic outcomes.

Market Forecasts

By 2030, the Estradiol Valerate segment within the estrogen therapy market could reach USD 4.5-5 billion globally, representing a CAGR of approximately 8%. Key catalysts include new product launches, expanding indications, and supportive regulatory pathways.

Competitive Landscape

Agile pharmaceutical firms focusing on innovation are expected to gain market share. Strategic collaborations and licensing agreements will catalyze access to novel formulations and indications. Patent cliffs may also lead to increased generic competition, putting pressure on prices but expanding accessibility.

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Key Takeaways

• Clinical advancements position Estradiol Valerate as a versatile agent with expanding indications, including menopausal management, osteoporosis, breast cancer, and transgender health. Ongoing trials are crucial for delineating its full therapeutic scope and safety profile.

• Market dynamics reflect steady growth driven by demographic shifts, medical needs, and product innovation. Regulatory trends necessitate ongoing safety assessments but do not significantly impede market expansion.

• Future projections are optimistic, with compound annual growth rates around 6-8% anticipated over the next five years. Innovations in delivery systems and personalized therapy frameworks will be significant growth enablers.

• Strategic focus for stakeholders should include investment in novel formulations, development of new indications, and deepening penetration into emerging markets. Collaboration with regulatory authorities and continuous safety evaluations remain critical.

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FAQs

1. What are the main therapeutic uses of Estradiol Valerate?
E2V is primarily used for hormone replacement therapy in menopausal women, contraception, and as part of transgender hormone therapy. Emerging uses include osteoporosis management and adjunct therapy in certain breast cancers.

2. How does Estradiol Valerate differ from other estrogen formulations?
E2V is a long-acting ester of estradiol, offering sustained hormone levels via injectable or transdermal forms. Its pharmacokinetic profile provides a gradual release, reducing dosing frequency and improving compliance.

3. What safety concerns are associated with Estradiol Valerate?
Risks include thromboembolic events, endometrial hyperplasia, and potential links to certain cancers. New formulations aim to mitigate these risks, but ongoing safety evaluations are essential.

4. What are the key factors influencing Estradiol Valerate's market growth?
Demographic increases in menopausal and transgender populations, innovation in delivery systems, expanding indications, and regulatory support are principal growth drivers.

5. When might E2V receive regulatory approval for new indications?
Based on current trial progress, approvals for osteoporosis and breast cancer indications could occur within the next 3-5 years, contingent on positive phase III trial outcomes and regulatory review.

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References

[1] Menopause, 2022, “Efficacy and Safety of Long-Acting Estradiol Valerate in Menopausal Symptom Management.”
[2] MarketWatch, 2023, “Global Estrogen Therapy Market Size & Trends.”