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Last Updated: April 25, 2025

CLINICAL TRIALS PROFILE FOR ESTROGENS, CONJUGATED


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All Clinical Trials for Estrogens, Conjugated

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Estrogens, Conjugated

Condition Name

Condition Name for Estrogens, Conjugated
Intervention Trials
Menopause 14
Osteoporosis 9
Postmenopause 8
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Condition MeSH

Condition MeSH for Estrogens, Conjugated
Intervention Trials
Osteoporosis 9
Breast Neoplasms 6
Atrophy 3
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Clinical Trial Locations for Estrogens, Conjugated

Trials by Country

Trials by Country for Estrogens, Conjugated
Location Trials
United States 359
Australia 3
Brazil 3
Mexico 3
Colombia 3
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Trials by US State

Trials by US State for Estrogens, Conjugated
Location Trials
Pennsylvania 18
California 18
Florida 17
North Carolina 14
Texas 13
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Clinical Trial Progress for Estrogens, Conjugated

Clinical Trial Phase

Clinical Trial Phase for Estrogens, Conjugated
Clinical Trial Phase Trials
Phase 4 10
Phase 3 19
Phase 2 10
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Clinical Trial Status

Clinical Trial Status for Estrogens, Conjugated
Clinical Trial Phase Trials
Completed 41
Terminated 7
Recruiting 5
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Clinical Trial Sponsors for Estrogens, Conjugated

Sponsor Name

Sponsor Name for Estrogens, Conjugated
Sponsor Trials
Wyeth is now a wholly owned subsidiary of Pfizer 13
Pfizer 10
National Cancer Institute (NCI) 7
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Sponsor Type

Sponsor Type for Estrogens, Conjugated
Sponsor Trials
Other 78
Industry 29
NIH 21
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Conjugated Estrogens: Clinical Trials, Market Analysis, and Projections

Introduction to Conjugated Estrogens

Conjugated estrogens, often referred to by brand names like Premarin, are a type of hormone therapy widely used in the treatment of menopausal symptoms, prevention of osteoporosis, and in some cases, for gender reassignment therapy. This article will delve into the latest clinical trials, market analysis, and projections for conjugated estrogens.

Clinical Trials and Safety Profile

Ovarian and Endometrial Cancer Risk

Recent findings from the Women's Health Initiative (WHI) clinical trials have provided significant insights into the safety profile of conjugated estrogens. A study presented at the 2024 ASCO Annual Meeting revealed that treatment with conjugated equine estrogen (CEE) alone was associated with a significantly increased incidence and mortality of ovarian cancer. However, when CEE was combined with medroxyprogesterone acetate (MPA) in postmenopausal women with an intact uterus, there was no increased risk of ovarian cancer compared to the placebo group. This combination also significantly reduced the incidence of endometrial cancer[1].

Cardiovascular and Breast Cancer Risks

The WHI trials also examined the effects of conjugated estrogens on cardiovascular health and breast cancer risk. For women receiving CEE alone, there was a non-significant reduction in coronary heart disease (CHD) events in those who were less than 10 years post-menopause. However, the combination of CEE and MPA showed a non-significant increased risk of CHD events compared to the placebo group. Regarding breast cancer, the estrogen-alone trial did not show an increased risk, but the estrogen plus progestin trial did, with larger and more advanced cancers diagnosed in the treatment group[3].

Other Clinical Findings

Conjugated estrogens have been shown to reduce the risk of hip fractures and endometrial hyperplasia. However, they can increase the risk of abnormal mammograms, necessitating regular breast examinations and mammography screenings[3].

Market Analysis

Global Market Size and Growth

The global conjugated estrogen market is projected to grow significantly over the next few years. The market size is estimated to expand from 2019 to 2031, with a focus on market trends, drivers, opportunities, and restraints. The base year for calculations is 2023, and the forecast period extends from 2025 to 2031[2].

Segment Analysis

The conjugated estrogen market can be segmented by type, delivery method, and region. By type, the market includes tablets, creams, and other formulations. Tablets have a significant impact on the market due to their ease of use and high patient compliance. The estrogen segment dominates the market, particularly in the context of gender reassignment therapy, where it is the primary hormone treatment for transwomen[2][5].

Regional Analysis

The market is expected to be dominated by regions with high healthcare spending and advanced medical infrastructure. The U.S. market, for example, is significant due to the high demand for hormone therapies, including conjugated estrogens for both menopausal symptoms and gender reassignment[5].

Distribution Channels

The distribution of conjugated estrogens is primarily through retail pharmacies, which held a revenue share of 56.35% in 2022. However, online platforms are expected to grow at a CAGR of 5.83% from 2023 to 2030, driven by increased internet accessibility and the convenience of telemedicine[5].

Market Projections

Revenue Growth

The U.S. sex reassignment hormone therapy market, which includes conjugated estrogens, was estimated at USD 1.6 billion in 2022 and is expected to grow at a CAGR of 4.05% from 2023 to 2030, reaching USD 2.23 billion by 2030. The estrogen segment, in particular, held the largest revenue share of 41.6% in 2022 and is anticipated to continue growing due to the rising demand for male-to-female treatment procedures[5].

Key Players and Strategies

Major players in the market, such as Pfizer Inc., Viatris Inc., AbbVie Inc., and others, are adopting various strategies to enhance their market presence. These include new product launches, acquisitions, partnerships, and improvements in packaging and distribution. For instance, Pfizer Inc. recently announced the return of DUAVEE (conjugated estrogens) to the market with improved packaging after a voluntary recall[5].

Future Outlook

Technological Advancements

The market is expected to benefit from technological advancements in hormone therapy, including new formulations and delivery methods. The increasing use of telemedicine and online platforms will also enhance accessibility and convenience for patients[5].

Regulatory and Government Support

Government support through awareness programs and policies is anticipated to drive the market growth. Increasing efforts by key market players in developing highly efficient novel hormone therapies will also contribute to the market's expansion[5].

Key Takeaways

  • Clinical Trials: Conjugated estrogens alone increase ovarian cancer risk but, when combined with progestin, do not increase this risk and reduce endometrial cancer incidence.
  • Market Size: The global conjugated estrogen market is projected to grow significantly, with the U.S. sex reassignment hormone therapy market expected to reach USD 2.23 billion by 2030.
  • Segment Analysis: The estrogen segment dominates the market, particularly in gender reassignment therapy.
  • Distribution Channels: Retail pharmacies currently dominate, but online platforms are expected to grow rapidly.
  • Key Players: Major pharmaceutical companies are enhancing their market presence through various strategies.

FAQs

What are the primary uses of conjugated estrogens?

Conjugated estrogens are primarily used to treat menopausal symptoms, prevent osteoporosis, and in gender reassignment therapy for transwomen.

What are the risks associated with conjugated estrogens?

Conjugated estrogens are associated with increased risks of ovarian cancer when used alone, but this risk is mitigated when combined with progestin. They also increase the risk of breast cancer and cardiovascular events in some cases.

Which segment dominates the conjugated estrogen market?

The estrogen segment, particularly in the context of gender reassignment therapy, dominates the market.

What is the projected growth rate of the conjugated estrogen market?

The U.S. sex reassignment hormone therapy market, which includes conjugated estrogens, is expected to grow at a CAGR of 4.05% from 2023 to 2030.

How are conjugated estrogens distributed?

Conjugated estrogens are primarily distributed through retail pharmacies, but online platforms are expected to grow significantly in the future.

Sources

  1. Long-Term Findings Clarify Role of Estrogen Therapy on Ovarian and Endometrial Cancer Incidence - onclive.com
  2. Conjugated Estrogen Market Report 2024 (Global Edition) - cognitivemarketresearch.com
  3. FDA: Conjugated Estrogens - accessdata.fda.gov
  4. UCSF Breast Cancer Clinical Trials - clinicaltrials.ucsf.edu
  5. U.S. Sex Reassignment Hormone Therapy Market Report, 2030 - grandviewresearch.com

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