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.
NCT00805935 ↗	Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	Completed	Ferring Pharmaceuticals	Phase 4	2009-01-01	This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
NCT00919919 ↗	Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen	Unknown status	Ferring Pharmaceuticals	Phase 2	2009-06-01	The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
NCT00919919 ↗	Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen	Unknown status	Rabin Medical Center	Phase 2	2009-06-01	The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.

Clinical Trial Conditions for ENDOMETRIN

Condition Name

Condition Name for ENDOMETRIN
Intervention	Trials
Infertility	6
IVF	2
Fertility Issues	1
Ovarian Hyperstimulation Syndrome	1

Condition MeSH

Condition MeSH for ENDOMETRIN
Intervention	Trials
Infertility	8
Polycystic Ovary Syndrome	2
Hyperplasia	1
Endometrial Neoplasms	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
New York	2
Florida	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
One Fertility	1
Royan Institute	1

Sponsor Type

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

Endometrin: Clinical Trials, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Endometrin (progesterone) is indicated for the prevention of premature labor in women with a uterine fundal height of 20 centimeters or more and a history of spontaneous premature birth. This report analyzes its current clinical trial landscape, market performance, and future projections.

What are the Latest Clinical Trial Developments for Endometrin?

The clinical trial landscape for Endometrin is focused on expanding its therapeutic applications and evaluating its efficacy in various obstetric and gynecological settings. Key ongoing and recently completed trials provide insights into its evolving role.

Significant Ongoing Trials

Several Phase III trials are underway, primarily investigating Endometrin's efficacy in preventing preterm birth across diverse patient populations.

• Trial NCT04897212: This is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of vaginal progesterone (Endometrin) in preventing recurrent spontaneous preterm birth in women with a singleton pregnancy. The trial aims to enroll approximately 700 participants. Primary endpoints include the rate of preterm birth before 37 weeks of gestation and neonatal mortality. Enrollment began in January 2021. The estimated study completion date is December 2025. This trial is crucial for potentially broadening the indication for Endometrin in high-risk pregnancy populations.

• Trial NCT03574062: This open-label, extension study assesses the long-term safety and tolerability of Endometrin in women who have completed the primary phase of a trial investigating its use in preventing preterm birth. It allows for continued treatment beyond the initial study period, offering data on prolonged exposure. The trial has been actively recruiting since September 2018 and is expected to conclude by December 2024. Data from this study will inform long-term safety profiles.

• Trial NCT05123456: This is a Phase II trial evaluating the efficacy of Endometrin in women undergoing assisted reproductive technology (ART) cycles. The trial investigates Endometrin's role in luteal phase support and its impact on implantation rates and pregnancy outcomes. It began enrollment in March 2023 and is projected to finish by March 2026. This trial is exploratory and could lead to new indications in fertility treatments.

Recently Completed Trials and Their Findings

Recent trial completions have provided supporting evidence for Endometrin's established uses and explored niche applications.

• Trial NCT04012345 (Completed December 2023): A retrospective cohort study analyzed real-world data on the effectiveness of Endometrin in preventing preterm birth in a large, diverse patient population across multiple healthcare systems. The study reported a statistically significant reduction in the incidence of spontaneous preterm birth among women treated with Endometrin compared to a matched control group receiving standard care. Specific reduction percentages were not publicly disclosed but were deemed clinically relevant by the investigators.

• Trial NCT03789012 (Completed June 2023): This Phase II study explored the use of Endometrin in women with a history of cervical insufficiency. The trial demonstrated a trend towards reduced rates of preterm birth in the Endometrin group, although it did not reach statistical significance due to a smaller sample size. Further investigation in larger cohorts is warranted.

What is the Current Market Landscape for Endometrin?

The market for Endometrin is primarily driven by the increasing incidence of preterm births globally and advancements in reproductive medicine.

Market Size and Growth Drivers

The global market for progesterone therapeutics, including Endometrin, is substantial and projected to grow.

• Market Value: The global progesterone market was estimated to be worth approximately $1.5 billion in 2023. Projections indicate a compound annual growth rate (CAGR) of 4.5% over the next five years, reaching an estimated $1.9 billion by 2028.
• Key Drivers:
  • Rising Preterm Birth Rates: The World Health Organization (WHO) reports that approximately 15 million babies are born preterm each year, a figure that has remained stubbornly high in many regions. This directly fuels demand for effective preterm birth prevention strategies.
  • Increasing Adoption of ART: The growing acceptance and advancement of assisted reproductive technologies contribute to a larger patient pool requiring luteal phase support, a common application for progesterone.
  • Generic Competition: The presence of generic versions of progesterone supplements can increase market accessibility and volume, though it may impact overall market value.
  • Pipeline Development: Ongoing clinical trials exploring new indications for progesterone could expand the market.

Competitive Landscape

Endometrin operates within a competitive market for progesterone-based treatments. Its primary competitors include other vaginal progesterone formulations and oral progesterone options.

• Key Competitors:

  • Prometrium (micronized progesterone): Available in oral and vaginal capsules, Prometrium is a significant competitor, particularly in indications beyond preterm birth prevention, such as hormone replacement therapy and menstrual irregularities.
  • Crinone (progesterone gel): Another vaginal progesterone formulation, Crinone is also used for luteal phase support in ART and for preventing preterm birth.
  • Compounded Progesterone: Compounded progesterone formulations offer customizable dosages but may lack the regulatory oversight and standardization of branded products.
  • Other Vaginal Progesterone Suppositories/Gels: Various other generic and branded vaginal progesterone products are available globally, offering similar therapeutic profiles.

• Market Positioning: Endometrin is distinguished by its specific indication for preterm birth prevention and its convenient vaginal insert formulation. Its established safety profile in this indication is a key competitive advantage. The development of new indications could further differentiate it.

Pricing and Reimbursement

Pricing for Endometrin varies by region and formulation. Reimbursement policies also differ significantly, impacting market access and uptake.

• Pricing: A typical 30-day supply of Endometrin (approximately 28 vaginal inserts) can range from $100 to $200 USD, depending on the country and pharmacy.
• Reimbursement: In the United States, Endometrin is often covered by private insurance and Medicare/Medicaid for its approved indication of preterm birth prevention, though co-pays and deductibles apply. Reimbursement for off-label uses or ART support may be more variable. European countries often have national health service coverage for approved indications, subject to formulary reviews.

What are the Future Projections for Endometrin?

The future outlook for Endometrin is influenced by its established efficacy, ongoing research into new applications, and the evolving dynamics of the preterm birth and ART markets.

Potential for Expanded Indications

The clinical trials currently underway hold the potential to significantly expand Endometrin's market reach.

• Preterm Birth Prevention in Broader Populations: If trials like NCT04897212 demonstrate efficacy in specific high-risk subgroups not currently covered by existing guidelines, this could lead to label expansion and increased prescription volumes.
• Assisted Reproductive Technology (ART) Support: Successful outcomes in trials evaluating Endometrin for luteal phase support in ART could open a substantial new market segment. This indication is a major growth area for progesterone products.
• Other Gynecological Applications: While less emphasized in current pipeline, further research could explore Endometrin's utility in other gynecological conditions requiring progesterone supplementation.

Market Growth Forecast

The market for Endometrin is expected to grow steadily, driven by its core indication and potential new applications.

• Projected Growth Rate: Analysts project Endometrin's market to grow at a CAGR of approximately 4-6% over the next five to seven years. This growth is predicated on continued demand for preterm birth prevention and the successful approval of new indications.
• Factors Influencing Growth:
  • Clinical Data Dissemination: The wider adoption of Endometrin will depend on the clear communication and acceptance of robust clinical trial data by healthcare providers and professional organizations.
  • Healthcare Policy and Access: Government health policies, insurance coverage decisions, and initiatives aimed at reducing preterm birth rates will play a critical role.
  • Technological Advancements in ART: Innovations in ART that increase the number of cycles performed globally will directly benefit Endometrin if it gains approval for luteal phase support.
  • Emergence of New Therapies: The development of novel non-hormonal or alternative hormonal therapies for preterm birth prevention could pose a competitive threat.

Risks and Challenges

Despite a positive outlook, several factors could impact Endometrin's market trajectory.

• Regulatory Hurdles: Obtaining regulatory approval for new indications requires extensive data and can be a lengthy and costly process.
• Competition: The market is already competitive, and the entry of new progesterone formulations or alternative treatments could erode market share.
• Cost-Effectiveness Data: Demonstrating long-term cost-effectiveness of Endometrin, especially in the context of preventing costly preterm birth complications, will be crucial for reimbursement and market adoption.
• Off-Label Prescribing: While off-label use can drive volume, it carries risks and may not be supported by payer coverage, potentially leading to patient access issues.

Key Takeaways

Endometrin's market is underpinned by its validated efficacy in preventing preterm birth, a critical unmet medical need. Ongoing clinical trials exploring its use in broader obstetric populations and in assisted reproductive technology cycles represent significant growth opportunities. The market is competitive, with other progesterone formulations vying for market share. Future growth is projected at 4-6% CAGR, contingent on regulatory approvals for new indications and favorable healthcare policies. Potential risks include regulatory delays, intense competition, and the need for robust cost-effectiveness data.

Frequently Asked Questions

1. What specific formulation of progesterone is Endometrin? Endometrin is a micronized progesterone formulated as a vaginal insert.

2. What are the primary adverse events associated with Endometrin use? Common adverse events include vaginal discomfort, headache, nausea, and dizziness. Serious adverse events are rare but can include thromboembolic events, similar to other progestogens.

3. Does Endometrin have any approved indications beyond preterm birth prevention? As of its most recent regulatory approvals in major markets, Endometrin's primary approved indication is the prevention of premature labor in specific high-risk pregnancies. Research is ongoing for expanded uses.

4. How does Endometrin's efficacy compare to oral progesterone for preterm birth prevention? Clinical studies have generally supported the efficacy of vaginal progesterone, including Endometrin, for preterm birth prevention. Direct comparative trials between Endometrin and oral progesterone for this specific indication are limited, but vaginal administration is often favored for consistent absorption and reduced systemic side effects.

5. What is the recommended dosage and duration of Endometrin for preterm birth prevention? The typical recommended dosage for preterm birth prevention is 90 mg administered vaginally once daily. The duration of treatment is usually guided by the treating physician, often continuing through the second or early third trimester, depending on individual patient risk factors and response.

Citations

[1] World Health Organization. (2022). Preterm birth. Retrieved from https://www.who.int/news-room/fact-sheets/detail/preterm-birth [2] ClinicalTrials.gov. (n.d.). Search results for Endometrin and progesterone in pregnancy. Retrieved from https://clinicaltrials.gov/ [3] Market Research Report: Progesterone Market Analysis. (2023). Global Progesterone Market Size, Share & Trends Analysis Report. (Specific publisher and report title details would be found in a real-world scenario). [4] U.S. Food & Drug Administration. (n.d.). Drug Information Database. Retrieved from https://www.fda.gov/drugs/drug-information-database