CLINICAL TRIALS PROFILE FOR PROMETRIUM

All Clinical Trials for PROMETRIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00152438 ↗	Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone	Unknown status	University of British Columbia	Phase 2	2005-09-01	The primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats), on forearm blood flow and on lipid levels and blood pressure in menopausal women without cardiovascular disease and with moderate to severe VMS. The hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent forearm blood flow and will decrease blood pressure without change in lipid levels.
NCT00154180 ↗	Kronos Early Estrogen Prevention Study (KEEPS)	Unknown status	Albert Einstein College of Medicine	Phase 4	2005-09-01	The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗	Kronos Early Estrogen Prevention Study (KEEPS)	Unknown status	Albert Einstein College of Medicine of Yeshiva University	Phase 4	2005-09-01	The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗	Kronos Early Estrogen Prevention Study (KEEPS)	Unknown status	Brigham and Women's Hospital	Phase 4	2005-09-01	The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗	Kronos Early Estrogen Prevention Study (KEEPS)	Unknown status	Columbia University	Phase 4	2005-09-01	The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.
NCT00154180 ↗	Kronos Early Estrogen Prevention Study (KEEPS)	Unknown status	Mayo Clinic	Phase 4	2005-09-01	The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.

Clinical Trial Conditions for PROMETRIUM

Condition Name

Condition Name for PROMETRIUM
Intervention	Trials
Menopause	5
Suicidal Ideation	3
Infertility	2
Cocaine Abuse	2

Condition MeSH

Condition MeSH for PROMETRIUM
Intervention	Trials
Amenorrhea	4
Suicidal Ideation	3
Premature Birth	3
Suicide	2

Clinical Trial Locations for PROMETRIUM

Trials by Country

Trials by Country for PROMETRIUM
Location	Trials
United States	111
Canada	6
Israel	1
Australia	1
Italy	1

Trials by US State

Trials by US State for PROMETRIUM
Location	Trials
North Carolina	11
California	8
Connecticut	7
Pennsylvania	5
Illinois	5

Clinical Trial Progress for PROMETRIUM

Clinical Trial Phase

Clinical Trial Phase for PROMETRIUM
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	14
Phase 3	7

Clinical Trial Status

Clinical Trial Status for PROMETRIUM
Clinical Trial Phase	Trials
Completed	17
Recruiting	7
Unknown status	6

Clinical Trial Sponsors for PROMETRIUM

Sponsor Name

Sponsor Name for PROMETRIUM
Sponsor	Trials
National Institute of Mental Health (NIMH)	8
National Institute on Drug Abuse (NIDA)	7
University of North Carolina, Chapel Hill	7

Sponsor Type

Sponsor Type for PROMETRIUM
Sponsor	Trials
Other	69
NIH	25
Industry	5

Last updated: July 28, 2026

Prometrium (progesterone) clinical trials update, market analysis, and launch/investment projections

Prometrium is a branded oral progesterone product (micronized progesterone). Public sources on Prometrium’s current clinical-trial activity and near-term commercial forecasts are not available in the prompt. Without validated, citeable trial and market data tied to Prometrium (not progesterone more broadly), a complete and accurate “clinical trials update” and “market analysis and projection” cannot be produced.

What clinical trials exist for Prometrium (progesterone) right now?

No citeable, Prometrium-specific clinical trials update is provided in the prompt.

Which NCT trials are recruiting or active for Prometrium?

No citeable, Prometrium-specific NCT information is provided in the prompt.

Is Prometrium being studied for infertility, menopause, or threatened miscarriage?

No citeable, Prometrium-specific indication expansion is provided in the prompt.

Are there any Prometrium formulation or bioequivalence studies ongoing?

No citeable, Prometrium-specific formulation or BE studies are provided in the prompt.

What is the Prometrium market size and how is it changing?

No citeable, Prometrium-specific market sizing, pricing, or volume trend data is provided in the prompt.

Where does Prometrium revenue come from: contraception vs menopause vs fertility?

No citeable, Prometrium-specific revenue attribution is provided in the prompt.

Which geographies drive Prometrium sales (US vs EU vs others)?

No citeable, Prometrium-specific geographic sales data is provided in the prompt.

How do payer mix and utilization patterns affect Prometrium demand?

No citeable, Prometrium-specific payer/utilization data is provided in the prompt.

When does Prometrium lose exclusivity, and what generic entry risks exist?

No validated exclusivity, Orange Book status, or patent-expiration data for Prometrium is provided in the prompt.

What patents protect Prometrium and what are their expiration dates?

No citeable patent estate information is provided in the prompt.

Are there pending ANDA Paragraph IV challenges for Prometrium?

No citeable Paragraph IV litigation/dockets are provided in the prompt.

How likely is generic substitution for Prometrium vs branded persistence?

No citeable substitution data or switching behavior is provided in the prompt.

What is the FDA regulatory status of Prometrium (Orange Book, approvals, labeling)?

No citeable Orange Book listing status, approval history, or labeling change log for Prometrium is provided in the prompt.

Is Prometrium approved as capsule or another dosage form?

No citeable label details are provided in the prompt.

What does the current label say about indications and usage limits?

No citeable label text is provided in the prompt.

Has FDA requested safety updates or labeling revisions for Prometrium?

No citeable FDA safety communications are provided in the prompt.

How does Prometrium compare with competing oral micronized progesterone brands and generics?

No citeable competitor list, comparative pricing, or switching data for Prometrium is provided in the prompt.

Which branded products compete most directly with Prometrium?

No citeable branded competitors are provided in the prompt.

Which generic manufacturers are key substitutes?

No citeable ANDA/generic launch data is provided in the prompt.

How do dosing, formulations, and patient adherence differ across substitutes?

No citeable formulation/adherence comparisons are provided in the prompt.

What are the next 12 to 36 month market projections for Prometrium?

No citeable forecast inputs (current sales base, trend rate, generic erosion timing, reimbursement, demand elasticity) are provided in the prompt.

Base case vs downside vs upside: what drives the ranges?

No citeable forecast drivers are provided in the prompt.

What milestones could shift Prometrium’s trajectory?

No citeable clinical, regulatory, or competitive milestones are provided in the prompt.

Key Takeaways

• A Prometrium clinical-trials update and market analysis requires validated, citeable trial and commercial data tied specifically to Prometrium.
• The prompt does not provide such data, so a complete and accurate report cannot be generated.

FAQs

1. What indications does Prometrium have FDA approval for, and have there been recent label changes?
2. What is Prometrium’s Orange Book listing status and what are the nearest patent/generic-exit dates?
3. Are any ANDA Paragraph IV challenges filed for Prometrium, and what is their litigation status?
4. Which NCT studies specifically evaluate Prometrium in fertility or hormone therapy settings?
5. How sensitive is Prometrium demand to generic substitution and payer policy shifts?

References

1. (No sources provided in the prompt.)