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.

Clinical Trial Conditions for ENDOMETRIN

Condition Name

Condition Name for ENDOMETRIN
Intervention	Trials
Infertility	6
IVF	2
Polycystic Ovarian Syndrome	1
Frozen Embryo Transfer	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 update, market analysis, and exclusivity-based projection (US + key markets)

Last updated: May 26, 2026

Endometrin (vaginal progesterone; active ingredient: progesterone) is an established women’s health product with ongoing competitive pressure from branded alternatives and compounded progesterone use. A precise, numbers-based projection for US sales, peak-year revenue, or near-term growth rate requires current FDA label specifics, confirmed launch/competitor status, and up-to-date public clinical trial records. No sufficient, citable source set is available in this context to produce a complete and accurate trial-by-trial update and market forecasting dataset.

What is Endometrin and what is its FDA regulatory status (label indications, dosing, exclusivity)

Endometrin is a vaginal progesterone product used as a progesterone replacement therapy in assisted reproduction settings and other conditions defined in its US label. The regulatory posture that drives market exclusivity and generic or AB-rated substitution risk is the FDA label and Orange Book listing (if applicable), plus any granted patent term extensions, pediatric exclusivity, and marketing exclusivity tied to the NDA/BLA.

What indications does Endometrin have that matter for market size

Endometrin’s commercial ceiling depends on how broadly its label covers clinician use in:

• Assisted reproductive technology (ART) protocols
• Progesterone support in fertility treatment cycles
• Vaginal progesterone replacement indications covered by the label

What regulatory pathway determines competition intensity

The practical competitive floor is set by whether the product is:

• An NDA with Orange Book-listed patents supporting brand exclusivity, or
• A product facing earlier generic entry dynamics, including AB substitution and lower-cost alternatives.

What clinical trials have been completed or are ongoing for Endometrin

A real “clinical trials update” requires a verified set of records from ClinicalTrials.gov (and other registries) listing:

• trial identifier
• protocol title and design
• enrolling status
• endpoints
• recruitment dates
• study results publication links

No such verified trial dataset is available here, so a complete and accurate update cannot be produced.

Which outcomes would move value for Endometrin

For a vaginal progesterone product, trial value is typically tied to:

• pregnancy outcomes in ART subgroups
• miscarriage reduction signals
• patient-reported tolerability and adherence
• safety signals tied to local irritation and systemic progesterone effects

How does Endometrin compare with progesterone vaginal alternatives (Crinone, Prometrium vaginal, generic progesterone)

Endometrin’s competitive position is determined by:

• formulation attributes (gel vs inserts vs capsules)
• dosing frequency and adherence profile
• cost per treatment cycle
• formulary status and payor contracting
• perceived tolerability and clinician familiarity

What formulation factors affect prescribing

Key prescribing drivers include:

• ability to follow clinic protocols with minimal patient dosing errors
• local tolerability (vaginal irritation/discomfort)
• consistency of dosing in ART settings

What matters for payors

Payor behavior is typically driven by:

• total cost of a treatment cycle
• pharmacy benefit manager (PBM) preferred product lists
• prior authorization criteria for fertility pathways

What patents protect Endometrin and what is the Orange Book status

A complete patent-protection map requires Orange Book data tied to the specific NDA number, including:

• listed patents (US numbers)
• patent expiration dates
• patent types (composition, formulation, method of use)
• patent-listed exclusivity codes
• any pediatric exclusivity or patent term adjustment

A verified Orange Book listing is not available in this context, so a complete and accurate patent estate summary cannot be produced.

How to interpret “listed patents” for brand vs generic risk

For progesterone products, generic entry risk often depends on:

• formulation and process patents
• method-of-use claims covering ART protocol steps
• label changes that narrow or broaden claim coverage

When does Endometrin lose exclusivity and what is the earliest plausible generic entry scenario

Exclusivity and launch timing depend on:

• NDA marketing exclusivity and any extensions
• patent expiration and enforceability windows
• Paragraph IV filing dates (if any) and settlement timelines
• regulatory acceptance of an ANDA for the same strength and route

No validated expiration or exclusivity timetable is available here.

What Paragraph IV challenges affect Endometrin (ANDA litigation, settlements, injunctions)

Paragraph IV litigation needs docket-level confirmation of:

• generic filers
• asserted patents
• complaint filing dates
• court decisions (including preliminary injunction grants or denials)
• settlement agreements and effective dates

A litigation dataset is not available here, so no accurate status summary can be produced.

What generic entry risks exist for Endometrin by dosage form and strength

Generic entry risk is dose and strength specific and depends on:

• bioequivalence and formulation similarity
• patent coverage of specific strengths
• manufacturing process constraints that trigger different infringement theories

No strength-specific and patent-specific dataset is provided here.

How strong is the patent estate for Endometrin (composition, formulation, method-of-use, manufacturing)

A strength assessment requires at least:

• claim breadth summary across key families
• remaining enforceable term
• known invalidity or non-infringement findings
• file history indicators

No patent estate corpus is available here.

What is the biosimilar risk for Endometrin

Endometrin is progesterone, not a biologic product. Biosimilar frameworks do not apply in the standard way used for monoclonal antibodies or recombinant proteins. However, analog competition from reformulations, generics, and compounded progesterone may affect market share.

A clinically specific biosimilar risk statement cannot be supported without a validated product classification and regulatory history set.

Market analysis: current competitive landscape and revenue drivers for Endometrin

A complete market analysis requires:

• current sales by geography
• treatment population size proxies for ART and luteal support
• channel mix (retail vs specialty vs fertility clinic distribution)
• payer coverage and formulary placement
• pricing history and SKU-level volume

No citable sales or pricing dataset is available in this context, so no numbers-based market analysis can be produced.

Key market drivers that typically affect vaginal progesterone products

• ART cycle volumes and utilization trends
• shift toward standardized luteal support protocols
• payer restrictions and preferred drug lists
• patient tolerance and clinic workflow integration

Market projection for Endometrin: base case, downside, and upside scenarios

A market projection needs:

• baseline revenue (current year, prior year)
• expected competitive changes (generic entry, price erosion, formulary swaps)
• expected label or guideline shifts impacting demand
• forecast period and methodology

No validated baseline or competitor event timeline is available here, so a complete and accurate projection cannot be produced.

Key Takeaways

• Endometrin is a vaginal progesterone product whose exclusivity, patent risks, and competitive dynamics depend on the Orange Book patent estate and any Paragraph IV litigation.
• A precise clinical trials update and numbers-based market projection cannot be produced without a verified dataset of FDA/Orange Book listings, patent expiration timelines, and current clinical trial registry records.

FAQs

1. What are the FDA label indications for Endometrin and how do they affect demand?
2. How do Orange Book-listed patents typically drive generic timing for vaginal progesterone products?
3. What competitor products most commonly substitute for Endometrin in fertility clinics?
4. What endpoints in ART progesterone trials most influence clinician adoption?
5. How does payor formulary placement change vaginal progesterone market share?

References

No sources were cited because no verifiable FDA/Orange Book, patent, litigation, trial registry, or market dataset is available in this context.