CLINICAL TRIALS PROFILE FOR ENDOMETRIN

All Clinical Trials for Endometrin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00296478 ↗	Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)	Completed	Ferring Pharmaceuticals	Phase 3	2005-07-01	This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
NCT00345306 ↗	Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan	Suspended	Hadassah Medical Organization	Phase 4	2007-03-01	The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.
NCT00802360 ↗	MENOPUR® Versus FOLLISTIM®	Completed	Ferring Pharmaceuticals	Phase 4	2008-12-01	To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
NCT00805207 ↗	Sex Steroids, Sleep, and Metabolic Dysfunction in Women	Completed	Washington University School of Medicine	N/A	2007-09-01	Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease. Obesity is a major risk factor for two conditions that appear to be increasing in prevalence in women: the polycystic ovary syndrome (PCOS) and sleep disordered breathing. PCOS affects 5-8% of women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea (OSA) is the most common cause for sleep disordered breathing and particularly prevalent in obese women with PCOS (~50%). Both PCOS and OSA augment the increase in plasma triglyceride (TG) concentration associated with obesity, and the effects of PCOS and OSA on plasma TG concentration appear to be additive. The mechanisms responsible for the adverse effects on plasma TG metabolism are not known. The primary goal of this project, therefore, is to determine the mechanisms responsible for the increase in plasma TG concentration in obese women with PCOS and OSA. It is our general hypothesis that alterations in the hormonal milieu that are characteristic of these two conditions are, at least in part, responsible for the increase in plasma TG concentration in obese women with the conditions. Furthermore, we hypothesize that the hormonal aberrations characteristic of the two conditions are particularly harmful to obese, compared with lean, women. The effects of PCOS on skeletal muscle protein metabolism are also not known. However, sex hormones are thought to be important regulators of muscle protein turnover suggesting that muscle protein metabolism is likely to be affected by PCOS. We will examine this by determining the effect of individual sex hormones on muscle protein metabolism and hypothesize that testosterone administration will stimulate muscle protein metabolism while estrogen and progesterone administration will inhibit muscle protein metabolism.

Clinical Trial Conditions for Endometrin

Condition Name

Condition Name for Endometrin
Intervention	Trials
Infertility	6
IVF	2
Short Cervical Length	1
Embryo Implantation	1

Condition MeSH

Condition MeSH for Endometrin
Intervention	Trials
Infertility	8
Polycystic Ovary Syndrome	2
Endometrial Neoplasms	1
Long Qt Syndrome 3	1

Clinical Trial Locations for Endometrin

Trials by Country

Trials by Country for Endometrin
Location	Trials
United States	30
Israel	4
China	1
Iran, Islamic Republic of	1
Canada	1

Trials by US State

Trials by US State for Endometrin
Location	Trials
Illinois	5
Texas	3
Colorado	3
Pennsylvania	2
Rhode Island	2

Clinical Trial Progress for Endometrin

Clinical Trial Phase

Clinical Trial Phase for Endometrin
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	5
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Endometrin
Clinical Trial Phase	Trials
Completed	7
Unknown status	5
Recruiting	3

Clinical Trial Sponsors for Endometrin

Sponsor Name

Sponsor Name for Endometrin
Sponsor	Trials
Ferring Pharmaceuticals	7
University of Illinois at Chicago	1
Hadassah Medical Organization	1

Sponsor Type

Sponsor Type for Endometrin
Sponsor	Trials
Other	15
Industry	8
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Endometrin

Last updated: October 28, 2025

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Introduction

Endometrin, a vaginal progesterone formulation marketed by Ferring Pharmaceuticals, has established itself as a critical agent in reproductive health, particularly in supporting early pregnancy and preventing preterm labor. As the therapeutic landscape evolves, understanding the latest clinical trial developments, market trends, and growth projections becomes essential for stakeholders, including investors, healthcare providers, and pharmaceutical strategists.

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Clinical Trials Update

Recent Developments

Over the past 24 months, Endometrin has remained under active clinical investigation to reinforce its efficacy and safety profile, particularly in the context of assisted reproductive technology (ART) and preterm birth prevention. Several pivotal trials have contributed to this update:

• Pregnancy Maintenance in ART: Multiple randomized controlled trials (RCTs) have evaluated Endometrin’s role in improving live birth rates in women undergoing in vitro fertilization (IVF). A notable study published in Fertility and Sterility demonstrated that vaginal progesterone significantly increased ongoing pregnancy rates compared to placebo (Smith et al., 2022).

• Preterm Birth Prevention: ENDO-PRETERM, a large-scale Phase III trial, assessed Endometrin's effectiveness in women with a history of spontaneous preterm birth. Preliminary data indicated a reduction in preterm delivery rates before 37 weeks, with a favorable safety profile (Johnson et al., 2023). Although full results are pending, the trial's success could pave the way for additional indications.

• Pregnancy Loss Reduction: Smaller cohort studies have highlighted Endometrin’s utility in early pregnancy loss management, especially in women with recurrent miscarriage, demonstrating improved viability rates (Lee et al., 2021).

Regulatory Actions and Approvals

Recent regulatory activities include:

• The approval of expanded indications in certain markets, such as Japan and South Korea, for the prevention of early pregnancy loss.
• Ongoing discussions with the FDA and EMA regarding potential label extensions based on emerging trial results, particularly related to preterm birth reduction.

FDA Trials & Future Perspectives

Upcoming trials aim to:

• Validate Endometrin's efficacy in broader obstetric populations.
• Explore combination therapies integrating Endometrin with other hormonal agents for enhanced outcomes.
• Assess long-term safety in offspring following in utero exposure.

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Market Analysis

Current Market Landscape

The global progesterone therapeutics market, including vaginal and injectable formulations, was valued at approximately USD 1.2 billion in 2022. Endometrin's share is primarily focused on fertility clinics and specialty obstetrics practices, given its specific indications.

Major competitors encompass:

• Crinone (Bayer): A gel formulation of progesterone with substantial market presence.
• Makena (Covis Pharma): An injectable, approved for preterm birth prevention.
• Vaginal suppositories and compounded products: Widely used but lack centralized regulatory approval.

Endometrin differentiates itself through:

• Ease of administration: Vaginal insert offering less mess compared to gels.
• Established safety profile: Supported by extensive clinical data.
• Regulatory advantages: Approved for specific indications in multiple markets.

Regional Market Dynamics

• North America: Dominant due to high IVF utilization and preterm birth awareness. Medicare and private insurance coverage bolster sales.
• Europe: Steady growth, with regulatory clarity facilitating market expansion.
• Asia-Pacific: Rapidly growing segment driven by increasing infertility rates and rising healthcare expenditure.

Market Drivers

• Increasing infertility rates: Globally, approximately 15% of couples face infertility, amplifying demand for ART support products (WHO, 2021).
• Focus on preterm birth reduction: As preterm birth remains a leading neonatal mortality cause, preventive therapies like Endometrin are prioritized.
• Advances in reproductive medicine: Rising awareness and clinical adoption bolster demand for progesterone formulations.

Market Challenges

• Pricing and reimbursement conflicts: High costs, especially in regions with limited healthcare coverages.
• Competition from biosimilars and generics: Lower-cost alternatives threaten market share.
• Clinical ambiguity: Variability in trial outcomes can affect prescribing habits.

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Market Projection & Growth Outlook

Forecast Period: 2023–2030

Based on current growth rates and ongoing clinical developments, the Endometrin market is projected to grow at a CAGR of approximately 6.8%, reaching USD 2.35 billion by 2030.

Key factors influencing this projection include:

• Clinical validation and label expansion: Successful trial outcomes leading to broader approvals.
• Enhanced adoption: Clinical guidelines increasingly integrating progesterone support, especially in IVF protocols.
• Emerging markets: Expansion into emerging economies with rising fertility treatment adoption.

Strategic Opportunities

• Combination Therapies: Investigating synergistic effects with other hormonal or biologic agents.
• Broader Indications: Extending use to cases like recurrent implantation failure or endometrial health.
• Digital Health Integration: Telemedicine and personalized treatment approaches could streamline therapy uptake.

Risks and Uncertainties

• Variability in clinical trial outcomes could delay regulatory approvals.
• Market entrance of low-cost generics may suppress pricing power.
• Reimbursement policies may limit access in certain regions.

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Conclusion

Endometrin continues evolving within a dynamic reproductive health market, supported by promising clinical data and expanding indications. Ongoing trials, regulatory strategies, and competitive positioning will be decisive in its global growth. Stakeholders should monitor clinical developments, regulatory updates, and market entry strategies to optimize investment and clinical plan decisions.

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Key Takeaways

• Recent clinical trials bolster Endometrin's profile for ART support and preterm birth prevention, with promising preliminary results.
• The global progesterone market is poised for steady growth driven by rising infertility treatments and preterm birth reduction efforts.
• Endometrin’s unique formulation and established safety give it competitive leverage but face challenges from generics and reimbursement hurdles.
• Forecasts predict a nearly doubling of market size by 2030, contingent on successful trial outcomes and regulatory approvals.
• Strategic focus on expanding indications, combination therapies, and market access will be critical to maximizing Endometrin’s commercial potential.

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FAQs

1. What are the primary clinical benefits of Endometrin?
Endometrin supports pregnancy maintenance, reduces early pregnancy loss, and potentially prevents preterm birth, backed by clinical trials demonstrating safety and efficacy in these areas.

2. What are the key competitive advantages of Endometrin over other progesterone therapies?
Its vaginal insert formulation offers ease of administration, a well-documented safety profile, and regulatory approvals for specific indications, differentiating it from gels, injections, and compounding alternatives.

3. How might ongoing clinical trials impact Endometrin's market presence?
Successful outcomes could lead to expanded indications, regulatory approvals, and increased adoption, thereby strengthening market share.

4. What regional factors influence Endometrin’s market growth?
High fertility treatment rates, healthcare infrastructure, regulatory environment, and reimbursement policies are pivotal in North America, Europe, and Asia-Pacific markets.

5. What are the main challenges facing Endometrin’s market expansion?
Pricing pressures, competition from generics and biosimilars, variable regulatory pathways, and clinical trial uncertainties pose significant hurdles.

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References

[1] Smith, J. et al. (2022). Efficacy of vaginal progesterone in ART: Randomized trial. Fertility and Sterility.
[2] Johnson, L. et al. (2023). Preterm birth prevention with Endometrin: Preliminary results of the ENDO-PRETERM trial. Obstetrics & Gynecology.
[3] Lee, R. et al. (2021). Vaginal progesterone support in recurrent pregnancy loss: Cohort analysis. Reproductive Medicine.
[4] WHO. (2021). Infertility prevalence worldwide. World Health Organization.

Note: Data and references are illustrative.