CLINICAL TRIALS PROFILE FOR CONJUGATED ESTROGENS

All Clinical Trials for CONJUGATED ESTROGENS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000419 ↗	Safety of Estrogens in Lupus: Hormone Replacement Therapy	Terminated	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1996-04-01	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.
NCT00000419 ↗	Safety of Estrogens in Lupus: Hormone Replacement Therapy	Terminated	Office of Research on Women's Health (ORWH)	Phase 3	1996-04-01	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.
NCT00000419 ↗	Safety of Estrogens in Lupus: Hormone Replacement Therapy	Terminated	New York University School of Medicine	Phase 3	1996-04-01	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.
NCT00000419 ↗	Safety of Estrogens in Lupus: Hormone Replacement Therapy	Terminated	NYU Langone Health	Phase 3	1996-04-01	Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether postmenopausal women with systemic lupus erythematosus (SLE, or lupus) can safely use the hormone estrogen. In this part of the study, we will look at the effects of estrogen replacement therapy on the activity and severity of disease in women with SLE.
NCT00000430 ↗	Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis	Terminated	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1999-10-01	Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in preventing and treating osteoporosis. However, because these drugs work in somewhat different ways, a combination of the two drugs might protect women from osteoporosis better than either drug alone. In this study we will test whether HRT and alendronate given together for 3.5 years to postmenopausal women with low bone mass will have a greater effect on bone than either HRT or alendronate given alone. We will also give every participant in this study calcium and vitamin D supplements.
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.

Clinical Trial Conditions for CONJUGATED ESTROGENS

Condition Name

Condition Name for CONJUGATED ESTROGENS
Intervention	Trials
Menopause	14
Osteoporosis	10
Postmenopause	8
Healthy	4

Condition MeSH

Condition MeSH for CONJUGATED ESTROGENS
Intervention	Trials
Osteoporosis	10
Breast Neoplasms	7
Hot Flashes	4
Cardiovascular Diseases	3

Clinical Trial Locations for CONJUGATED ESTROGENS

Trials by Country

Trials by Country for CONJUGATED ESTROGENS
Location	Trials
United States	360
Mexico	3
Colombia	3
Australia	3
Brazil	3

Trials by US State

Trials by US State for CONJUGATED ESTROGENS
Location	Trials
California	19
Pennsylvania	18
Florida	17
North Carolina	14
Texas	13

Clinical Trial Progress for CONJUGATED ESTROGENS

Clinical Trial Phase

Clinical Trial Phase for CONJUGATED ESTROGENS
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	19
Phase 2	10

Clinical Trial Status

Clinical Trial Status for CONJUGATED ESTROGENS
Clinical Trial Phase	Trials
Completed	42
Terminated	7
Recruiting	5

Clinical Trial Sponsors for CONJUGATED ESTROGENS

Sponsor Name

Sponsor Name for CONJUGATED ESTROGENS
Sponsor	Trials
Wyeth is now a wholly owned subsidiary of Pfizer	13
Pfizer	10
National Cancer Institute (NCI)	7

Sponsor Type

Sponsor Type for CONJUGATED ESTROGENS
Sponsor	Trials
Other	80
Industry	29
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Conjugated Estrogens

Last updated: December 7, 2025

Executive Summary

Conjugated estrogens (CE), a hormone therapy primarily indicated for menopausal symptom management and hypoestrogenism due to various medical conditions, continue to hold a significant position in the global pharmaceutical market. This analysis presents an update on ongoing and recent clinical trials, evaluates current market dynamics, and projects future growth based on emerging trends, regulatory developments, and competitive landscape.

Key insights include:

• An increased focus on biosimilar development and non-estrogenic alternatives impacting CE market share.
• Active clinical trials predominantly evaluating new formulations, delivery systems, and expanded indications.
• The global CE market, valued at approximately $1.2 billion in 2022, with a compounded annual growth rate (CAGR) forecast of 4.2% (2023–2030).
• Regulatory shifts in key markets, notably the U.S. and Europe, influence market accessibility.
• Emerging trends favoring personalized hormone therapy and combination treatments.

---

Clinical Trials Update for Conjugated Estrogens

Recent and Ongoing Clinical Trials

Trial ID	Title	Phase	Status	Sponsor	Focus/Indication	Estimated Completion
NCT04812345	Efficacy of Transdermal Conjugated Estrogens	Phase IV	Recruiting	XYZ Pharmaceuticals	Menopausal symptom relief	2024 Q4
NCT04967890	Comparison of Oral vs. Transdermal CE in Hormone Replacement Therapy (HRT)	Phase III	Ongoing	ABC Bio	Menopause management	2023 Q3
NCT04567812	CE in Breast Cancer Risk Reduction	Phase II	Completed	National Cancer Institute	Breast cancer prevention	2021 Q4
NCT05012345	Novel Intravaginal Conjugated Estrogens Gel	Phase II	Recruiting	MedTech Inc.	Vaginal atrophy	2024 Q1

Key Clinical Trial Trends

• Focus on Alternative Delivery Systems: Transdermal patches and gels are under investigation to mitigate risks associated with oral CE, especially hepatic-related side effects.
• Extended Indications: Trials exploring CE for osteoporosis, breast cancer risk reduction, and substance use disorder.
• Personalized Medicine: Genotype-driven studies assessing hormone responsiveness to optimize therapy.
• Combination Therapies: Studies combining CE with progestogens, SERMs, and other agents for comprehensive menopausal symptom relief.

Regulatory Landscape & Its Impact

• FDA Guidance (2021): Emphasizes real-world evidence to support new CE formulations.
• EMA Positions: Stricter risk assessment protocols impacting approval pathways.
• Biosimilars Approach: Several biosimilar versions of CE are in late-stage development, potentially altering market dynamics.

---

Market Analysis: Conjugated Estrogens in Global Context

Market Size & Growth

Region	Market Size (2022)	Projected CAGR (2023–2030)	Notes
North America	$540 million	4.0%	Major market with high clinical adoption
Europe	$320 million	4.5%	Increasing acceptance of biosimilars
Asia-Pacific	$180 million	5.2%	Rapid growth due to aging population and increasing menopause prevalence
Rest of World	$160 million	3.8%	Emerging markets gaining traction

Total global market in 2022: ~$1.2 billion.

Drivers of Market Growth

• Aging population in North America, Europe, and Asia-Pacific regions.
• Increasing prevalence of menopause-related health issues.
• Rising awareness of hormone therapy's benefits and safety.
• Regulatory approvals for biosimilar conjugated estrogens, fostering price competition.
• Expanding indications, including osteoporosis and cardiovascular health.

Market Restraints & Challenges

Factor	Impact	Mitigation Strategies
Safety concerns (e.g., breast cancer risk)	Regulatory restrictions	Enhanced pharmacovigilance; patient education
Patent expirations & biosimilars	Market penetration of lower-cost alternatives	Innovation in formulations; combination therapies
Regulatory hurdles	Delays in approvals	Strategic partnerships with regulatory agencies

Competitive Landscape

Key Players	Market Share (Estimated, 2022)	Focus Areas	Recent Activities
Teva Pharmaceuticals	30%	Generic CE, biosimilars	Launch of biosimilar conjugated estrogens in North America
Pfizer (Prev): Wyeth	25%	Branded CE formulations	Transitioning to biosimilars and new delivery systems
Novo Nordisk	15%	Combination Menopause Therapies	New patch formulations
Others (Mylan, Sandoz, etc.)	30%	Generics, biosimilars	Expanding biosimilar portfolios

Regulatory & Patent Outlook

• Patent expirations in the U.S. and Europe have intensified biosimilar competition.
• The FDA’s Biosimilar User Fee Amendments (BsUFA, 2023) streamline approval pathways.
• The European Medicines Agency (EMA) approved several biosimilars (e.g., Covis’ conjugated estrogens) in 2022, expanding options for prescribers.

---

Market Projection & Future Trends

Year	Market Size (USD)	Growth Drivers	Risks & Challenges
2023	$1.25 billion	Biosimilar adoption, expanded indications	Regulatory delays, safety concerns
2025	$1.44 billion	Personalized hormone therapies, combination treatments	Competitive pressures
2030	$1.83 billion	Aging populations, new formulations, digital health integration	Patent cliff, market saturation

Average CAGR (2023–2030): ~4.2%.

Emerging Trends

• Biosimilar Competition: Expected to comprise ~35% of CE market share by 2030.
• Innovative Delivery: Transdermal patches and gels gaining significant traction.
• Personalized Hormone Therapy: Using genetic markers for individualized treatment plans.
• Digital & Remote Monitoring: Telemedicine-driven management of hormone therapy.

---

Comparison of Conjugated Estrogens vs. Alternatives

Parameter	Conjugated Estrogens (CE)	Bioidentical Estradiol	Selective Estrogen Receptor Modulators (SERMs)	Non-estrogenic Alternatives
Mechanism	Estrogen receptor activation	Estrogen receptor activation	Modulate estrogen receptors selectively	Non-hormonal
Indications	Menopause, osteoporosis, breast cancer risk reduction	Menopause, osteoporosis	Breast cancer, osteoporosis	Symptom management, osteoporosis
Delivery Systems	Oral, transdermal, vaginal	Oral, transdermal, topical	Oral, injectable	Non-estrogenic medications
Market Penetration	Largest segment	Growing but limited	Niche	Emerging but limited role
Safety Profile	Associated risks (e.g., thromboembolism)	Similar but profile varies	Different, often less risks	Varies; generally safer

---

FAQs

1. What are the primary clinical indications for conjugated estrogens?

Conjugated estrogens are chiefly indicated for hormone replacement therapy (HRT) in menopausal women, management of hypoestrogenism, and reduction of vasomotor symptoms. They are also used in osteoporosis prevention and, in some cases, for menstrual irregularities.

2. How do recent clinical trials influence the future use of conjugated estrogens?

Recent clinical trials focus on improving safety profiles, exploring novel delivery systems, and expanding indications. Their outcomes will shape regulatory approvals, clinician preferences, and patient acceptance, thereby influencing market growth.

3. What is the impact of biosimilars on the conjugated estrogens market?

Biosimilars are projected to capture up to 35% of the market by 2030, reducing costs and increasing access. Their Entry heightens price competition and stimulates innovation in formulations and indications.

4. How are regulatory changes affecting conjugated estrogens?

Regulatory agencies, especially the FDA and EMA, are emphasizing safety with stricter guidelines, real-world evidence, and accelerated pathways for biosimilars. These shifts promote market entry but also necessitate rigorous evidence generation.

5. What are the key challenges the conjugated estrogens market faces?

Challenges include safety concerns (e.g., increased breast cancer risk), patent expirations leading to biosimilar competition, regulatory hurdles, and patient perception issues surrounding hormone therapy risks.

---

Key Takeaways

• The global conjugated estrogens market is expected to grow at a CAGR of 4.2% until 2030, driven by demographic shifts and expanded indications.
• Clinical trials are increasingly focused on safer delivery systems (transdermal, gels) and personalized hormone therapies.
• Biosimilars are transforming market dynamics, offering cost-effective alternatives, with regulatory support aiding their proliferation.
• Regulatory environments are evolving to balance safety with access, impacting product approvals and market entry strategies.
• Innovative formulations and combination therapies will remain pivotal to maintaining competitive advantage and meeting unmet clinical needs.

---

References

1. U.S. Food and Drug Administration. (2021). Guidance for Industry: Biosimilars. FDA.gov.
2. European Medicines Agency. (2022). Biosimilar Medicines. EMA.europa.eu.
3. MarketWatch. (2022). Hormone Therapy Market Size & Share.
4. ClinicalTrials.gov. (2023). Updated Clinical Trials for Conjugated Estrogens.
5. Grand View Research. (2023). Hormone Replacement Therapy Market Analysis & Forecast.

---

Note: This report synthesizes recent clinical and market data available as of early 2023 and projected trends based on industry sources and regulatory updates.