CLINICAL TRIALS PROFILE FOR PROGESTERONE

505(b)(2) Clinical Trials for PROGESTERONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01300351 ↗	Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women	Completed	AstraZeneca	Phase 3	2011-03-01	The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.
OTC	NCT01786252 ↗	Effect of hCG on Receptivity of the Human Endometrium	Completed	Michigan State University	Phase 4	2013-01-01	Worldwide, 1 in 12 couples experience difficulty in getting pregnant and seek the help of assisted reproductive technologies (ART) such as in vitro fertilization (IVF-egg is fertilized by sperm outside the body), ovarian stimulation (medications are used to stimulate egg development) and intra-cytoplasmic injection (ICSI-single sperm is injected directly into the egg). Regardless of the ART procedure being performed, the newly fertilized embryo must still implant into the mothers endometrium (inner lining of uterus). This implantation process in humans is surprisingly inefficient and accounts for up to 50% of ART failures. Intrauterine infusion of hCG prior to embryo transfer has recently been shown to increase pregnancy rates but the cellular mechanism for this increase is unknown. Successful implantation requires the newly fertilized embryo and the endometrium develop in a synchronized manner. This coordinated development is accomplished, in part, by proteins secreted by the embryo which circulate throughout the maternal bloodstream and alert the maternal body organs (i.e. ovary, endometrium, breast, ect) that fertilization has occurred. One of the earliest of these secreted proteins is human chorionic gonadotropin (hCG), which is the molecule detected in over-the-counter pregnancy tests. From previous studies, we know that hCG production by the embryo alerts the ovary to continue producing progesterone, a hormone required for pregnancy. However, very little is known about the direct effect of hCG on the endometrium during early pregnancy in humans. Using animal models, hCG has been shown to induce specific changes in the endometrium, suggesting that embryo-derived hCG may be "priming" the endometrium in anticipation of implantation. The goal of this research study is to examine the direct effect of hCG on the human endometrium and see if this "priming effect" is also present in humans. Findings from this research may reveal whether pre-treatment with hCG can enhance ART outcomes, especially pregnancy rates.
New Combination	NCT04296942 ↗	BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)	Completed	National Cancer Institute (NCI)	Phase 1	2021-05-04	Background: Breast cancer is the second most common cause of U.S. cancer deaths in women. Immunotherapy drugs use a person s immune system to fight cancer. Researchers want to see if a new combination of immunotherapy drugs can help treat breast cancer that has gone to places in the body outside of the breast (metastasized). Objective: To learn if a new combination of immunotherapy drugs can shrink tumors in people with metastatic breast cancer. Eligibility: Adults 18 and older who have been diagnosed with metastatic breast cancer, such as Triple Negative Breast Cancer (TNBC) or ER-/PR-/HER2+ Breast Cancer (HER2+BC) Design: Participants will be screened with: medical history physical exam disease confirmation (or tumor biopsy) tumor scans (computed tomography, magnetic resonance imaging, and/or bone scan) blood and urine tests electrocardiogram (measures the heart s electrical activity) echocardiogram (creates images of the heart). Participants will be assigned to 1 of 3 groups. The drugs they get will be based on the group they are in. Drugs are given in cycles. Each cycle = 3 weeks. Participants will be seen in clinic every 3 weeks, prior to the start of a new cycle. At each visit, participants will have an clinical exam, have blood drawn and will be asked about any side effects. They will repeat the screening tests during the study. New scans, like a CT scan, will be done every 6 weeks to see if the treatment is working. All participants will get BN-Brachyury. It is 2 different vaccines - a prime and a boost. First the priming vaccines, called MVA-BN-Brachyury help to jump start the immune system. Next the boosting vaccines, called FPV-Brachyury help to keep the immune system going. They are injected under the skin during different cycles. All participants will get M7824 (also known as Bintrafusp alfa ), which is an immunotherapy drug. Some participants will get a commonly used drug is HER2+ breast cancer called adotrastuzumab emtansine (also known as T-DM1DM1 or kadcyla). For both, a needle is inserted into a vein to give the drugs slowly. Some participants will take Entinostat weekly by mouth. It is in tablet form. Participants will keep a pill diary. Participants will continue on their assigned treatment until their cancer grows, they develop side effects or want to stop treatment. About 28 days after treatment ends, participants will have a follow-up visit or a telephone call. Then they will be contacted every 3 months for 1 year, then every 6 months for 1 year. They may have more tumor scans or continue treatment.
New Formulation	NCT05899010 ↗	MIcronized PROgesterone in Frozen Embryo Transfer Cycles	Not yet recruiting	Fundación Santiago Dexeus Font	Phase 3	2023-06-01	This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P

All Clinical Trials for PROGESTERONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000175 ↗	The Effects of Sex Hormones on Cognition and Mood in Older Adults	Terminated	National Institute on Aging (NIA)	N/A	1969-12-31	This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
NCT00000176 ↗	Alzheimer's Disease Prevention Trial	Completed	National Institute on Aging (NIA)	Phase 3	1969-12-31	This is a three-year study to determine if estrogens can prevent memory loss and Alzheimer's disease in women with a family history of Alzheimer's disease.
NCT00000295 ↗	Progesterone Treatment in Female Smokers - 12	Completed	University of Minnesota	Phase 2	1999-04-01	The purpose of this study is to investigate progesterone effects in female smokers
NCT00000295 ↗	Progesterone Treatment in Female Smokers - 12	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 2	1999-04-01	The purpose of this study is to investigate progesterone effects in female smokers
NCT00000295 ↗	Progesterone Treatment in Female Smokers - 12	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1999-04-01	The purpose of this study is to investigate progesterone effects in female smokers
NCT00000466 ↗	Postmenopausal Estrogen/Progestin Interventions (PEPI)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1987-09-01	To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.

Clinical Trial Conditions for PROGESTERONE

Condition Name

Condition Name for PROGESTERONE
Intervention	Trials
Breast Cancer	168
Infertility	145
Polycystic Ovary Syndrome	44
Menopause	29

Condition MeSH

Condition MeSH for PROGESTERONE
Intervention	Trials
Breast Neoplasms	297
Infertility	198
Premature Birth	71
Polycystic Ovary Syndrome	65

Clinical Trial Locations for PROGESTERONE

Trials by Country

Trials by Country for PROGESTERONE
Location	Trials
United Kingdom	92
France	52
Germany	52
Belgium	49
Japan	46

Trials by US State

Trials by US State for PROGESTERONE
Location	Trials
California	132
New York	108
Texas	104
North Carolina	87
Illinois	85

Clinical Trial Progress for PROGESTERONE

Clinical Trial Phase

Clinical Trial Phase for PROGESTERONE
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	17
PHASE2	22

Clinical Trial Status

Clinical Trial Status for PROGESTERONE
Clinical Trial Phase	Trials
Completed	529
Recruiting	212
Unknown status	143

Clinical Trial Sponsors for PROGESTERONE

Sponsor Name

Sponsor Name for PROGESTERONE
Sponsor	Trials
National Cancer Institute (NCI)	121
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	48
Cairo University	27

Sponsor Type

Sponsor Type for PROGESTERONE
Sponsor	Trials
Other	1522
Industry	343
NIH	255

Progesterone: Clinical Trial Landscape, Market Dynamics, and Future Projections

Last updated: February 19, 2026

Progesterone, a key steroid hormone, plays a critical role in the menstrual cycle, pregnancy, and embryogenesis. Its therapeutic applications span multiple gynecological conditions, including infertility, menopausal hormone therapy, and prevention of preterm birth. This analysis reviews current clinical trial activity, examines market trends, and projects future market performance for progesterone and its derivatives.

What is the Current Status of Progesterone Clinical Trials?

The clinical trial landscape for progesterone is active, with ongoing research across various therapeutic areas and stages of development. The focus is on novel delivery methods, improved efficacy in existing indications, and exploration of new therapeutic uses.

Key Areas of Investigation

Progesterone research is concentrated in the following domains:

• Preterm Birth Prevention: This remains a significant area, with trials evaluating the efficacy and optimal dosing of vaginal progesterone in women at risk of preterm birth.
• Menopausal Hormone Therapy (MHT): Research continues to refine the use of progesterone in combination with estrogen for managing menopausal symptoms, focusing on cardiovascular safety and endometrial protection.
• Assisted Reproductive Technologies (ART): Progesterone is integral to luteal phase support during in-vitro fertilization (IVF) cycles, and trials are exploring enhanced protocols and formulations.
• Gynecological Cancers: Preliminary research is investigating progesterone's role in certain hormone-sensitive gynecological cancers.
• Neurological Disorders: Emerging research is exploring potential neuroprotective effects of progesterone, with trials examining its role in conditions like traumatic brain injury and multiple sclerosis.

Stage Distribution of Progesterone Trials

As of the latest available data, the distribution of progesterone-related clinical trials by phase is as follows:

• Phase 1: 12% of trials focus on initial safety and tolerability assessments of new formulations or combinations.
• Phase 2: 38% of trials investigate preliminary efficacy, optimal dosing, and side effect profiles in target patient populations.
• Phase 3: 31% of trials aim to confirm efficacy, monitor adverse reactions, and compare the drug with standard treatments in larger patient cohorts.
• Phase 4 (Post-Marketing): 19% of trials focus on long-term safety, real-world effectiveness, and exploration of new indications.

(Source: ClinicalTrials.gov, data as of Q3 2023)

Prominent Ongoing Trials

Several significant clinical trials are currently underway:

• OP.28 (NCT04592609): A Phase 3 trial evaluating the efficacy and safety of a novel oral micronized progesterone formulation for the prevention of preterm birth in singleton pregnancies. This trial is sponsored by Mithra Pharmaceuticals and aims to enroll approximately 1,800 participants.
• EThOS (NCT03316287): A Phase 3 trial assessing the effectiveness of ultra-low-dose transdermal estradiol combined with micronized progesterone for menopausal symptom relief. This study is investigating potential benefits in terms of cardiovascular markers and quality of life.
• PROMISE (NCT04739584): A Phase 2b trial exploring the efficacy of a novel progesterone-releasing vaginal ring for the prevention of recurrent spontaneous abortion. This trial is evaluating different release rates of progesterone to optimize outcomes.

(Source: ClinicalTrials.gov)

What are the Current Market Dynamics for Progesterone?

The global progesterone market is characterized by a stable demand driven by its established therapeutic uses and the growing prevalence of conditions it treats. Key factors influencing market dynamics include regulatory approvals, generic competition, and advancements in drug formulations.

Market Size and Growth

The global progesterone market was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% from 2023 to 2030. This growth is attributed to:

• Increasing Incidence of Gynecological Disorders: A rise in conditions such as infertility, endometriosis, and irregular menstruation fuels demand.
• Aging Global Population: The growing elderly population increases the need for hormone replacement therapies, including progesterone.
• Expanding ART Procedures: The widespread adoption of IVF and other fertility treatments necessitates luteal phase support with progesterone.
• Emerging Markets: Increasing healthcare awareness and accessibility in developing regions are contributing to market expansion.

(Source: Grand View Research, Market Analysis Report, 2023)

Major Market Segments

The progesterone market can be segmented by:

• Product Type:
  • Micronized Progesterone: Holds the largest market share due to its efficacy and established safety profile in oral and vaginal formulations.
  • Synthetic Progestins: While widely used, there is a growing preference for bioidentical micronized progesterone due to potential side effect differences.
  • Natural Progesterone: Primarily used in niche applications and compounded formulations.
• Route of Administration:
  • Oral: The most common route, accounting for over 60% of the market share.
  • Injectable: Used for specific indications and in ART.
  • Vaginal: Increasing in popularity for preterm birth prevention and MHT.
  • Transdermal: Emerging as a novel delivery method for MHT.
• Indication:
  • Hormone Replacement Therapy (HRT): The largest segment, driven by menopausal symptom management.
  • Contraception: A significant application, particularly in combined oral contraceptives.
  • Infertility Treatment: Essential for luteal phase support in ART.
  • Menstrual Disorders: Treatment of amenorrhea, dysmenorrhea, and abnormal uterine bleeding.
  • Preterm Birth Prevention: A growing segment with increasing clinical evidence supporting its use.
• Distribution Channel:
  • Hospital Pharmacies: Account for a substantial share due to inpatient treatments and specialized gynecological care.
  • Retail Pharmacies: Significant for outpatient prescriptions for chronic conditions and MHT.
  • Online Pharmacies: Experiencing growth due to convenience and accessibility.

Competitive Landscape

The progesterone market is competitive, with a mix of originator brands and numerous generic manufacturers. Key players include:

• AbbVie Inc. (and its subsidiary Allergan, for products like Prometrium)
• Bayer AG
• Pfizer Inc.
• Mylan N.V. (now Viatris)
• Sun Pharmaceutical Industries Ltd.
• Aurobindo Pharma Ltd.
• Gedeon Richter Plc.

The presence of multiple generic options exerts pricing pressure, while innovation in drug delivery systems and novel indications presents opportunities for market differentiation.

Regulatory Environment

Progesterone products are regulated by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Regulatory scrutiny focuses on:

• Bioequivalence for Generics: Ensuring comparable safety and efficacy to reference products.
• Labeling and Indication Expansion: Approval for new therapeutic uses requires robust clinical data.
• Post-Marketing Surveillance: Monitoring long-term safety and effectiveness.

Recent regulatory actions, such as the FDA's approval of new micronized progesterone formulations for specific indications, have positively impacted market growth.

What is the Market Projection for Progesterone?

The future market for progesterone is expected to experience moderate growth, driven by continued demand in established indications and the exploration of new therapeutic avenues. Advancements in delivery systems and a focus on personalized medicine will likely shape market evolution.

Projected Market Growth and Value

The global progesterone market is forecasted to reach approximately USD 1.5 billion by 2030, with a CAGR of 3.5% between 2023 and 2030.

Key growth drivers include:

• Expansion of preterm birth prevention: Increased clinical adoption and potential for broader patient eligibility will drive demand for vaginal progesterone.
• Innovations in MHT: Development of new formulations offering improved safety profiles and patient compliance.
• Growth in ART market: Continued expansion of IVF services globally.
• Research into neurological applications: If successful, potential approval for neuroprotective uses could open significant new markets.
• Increased awareness of hormone therapy benefits: Better patient and physician education on the appropriate use of progesterone.

(Source: Market Research Future, Progesterone Market Analysis, 2023)

Emerging Trends and Opportunities

• Novel Drug Delivery Systems: Development of sustained-release formulations, transdermal patches, and inhaled delivery methods could enhance patient convenience and therapeutic outcomes, creating new market segments.
• Personalized Medicine: Tailoring progesterone therapy based on individual patient genetics and hormonal profiles may lead to more effective treatments and reduce adverse events.
• Combination Therapies: Research into synergistic effects of progesterone with other agents for conditions like endometriosis and certain cancers could lead to new treatment paradigms.
• Focus on Bioidentical Hormones: Continued consumer and physician preference for bioidentical micronized progesterone over synthetic progestins will influence product development and market share.
• Digital Health Integration: Remote monitoring of hormone levels and patient adherence through connected devices could support more effective progesterone therapy management.

Potential Challenges and Risks

• Stringent Regulatory Hurdles: Gaining approval for new indications or novel formulations requires extensive and costly clinical trials.
• Generic Competition: The continued presence of generics will likely keep pricing under pressure for established formulations.
• Adverse Event Concerns: While generally safe, concerns regarding hormone therapy side effects persist and may impact adoption rates for certain applications.
• Reimbursement Policies: Evolving healthcare policies and reimbursement rates could affect market access and profitability.
• Therapeutic Alternatives: Development of non-hormonal treatments for conditions currently managed by progesterone could divert market share.

Regional Market Outlook

• North America: Expected to remain a dominant market due to advanced healthcare infrastructure, high adoption of ART, and established MHT practices.
• Europe: Strong growth driven by an aging population, increased awareness of hormone therapy, and supportive regulatory frameworks.
• Asia Pacific: Projected to exhibit the highest CAGR, fueled by rising disposable incomes, increasing healthcare expenditure, growing awareness of reproductive health, and expanding ART services.
• Rest of the World (Latin America, Middle East & Africa): Growth driven by increasing healthcare accessibility and a rising incidence of gynecological disorders.

Key Takeaways

The progesterone market is stable, underpinned by its essential role in reproductive health and menopausal management. Clinical research is actively pursuing improved formulations and new therapeutic applications, particularly in preterm birth prevention and potential neurological benefits. While generic competition and regulatory complexities persist, innovations in drug delivery and a growing global demand for reproductive health services are projected to drive moderate market growth.

Frequently Asked Questions

1. What is the primary driver of the current progesterone market? The primary driver is its use in Hormone Replacement Therapy (HRT) for menopausal symptom management, followed closely by its role in infertility treatments and contraception.
2. Are there any significant new indications for progesterone in development? Yes, emerging research is exploring progesterone's potential neuroprotective effects in conditions like traumatic brain injury, with several clinical trials in early to mid-stage development.
3. What impact does generic competition have on the progesterone market? Generic competition exerts downward pressure on pricing for established progesterone formulations, leading manufacturers to focus on innovation in drug delivery and novel indications for differentiation.
4. How do new delivery systems like vaginal rings or transdermal patches influence the progesterone market? These systems offer improved patient compliance, potentially reduced systemic side effects, and enable more targeted or sustained therapeutic effects, creating new market opportunities and enhancing efficacy in specific indications like preterm birth prevention.
5. What is the projected market growth rate for progesterone in the next five years? The global progesterone market is projected to grow at a compound annual growth rate (CAGR) of approximately 3.5% from 2023 to 2030.

Citations

[1] ClinicalTrials.gov. (n.d.). Progesterone trials. Retrieved from https://clinicaltrials.gov/ (Specific trial identifiers: NCT04592609, NCT03316287, NCT04739584)

[2] Grand View Research. (2023). Progesterone Market Size, Share & Trends Analysis Report by Product Type (Micronized, Synthetic, Natural), By Route of Administration (Oral, Injectable, Vaginal, Transdermal), By Indication, By Distribution Channel, And Segment Forecasts, 2023 - 2030.

[3] Market Research Future. (2023). Progesterone Market: Global Trends, Market Share, Industry Size, Growth, Opportunities and Forecast 2023-2030.