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Vaginal Progesterone
Vaginal Progesterone is a Progestin Small molecule drug developed by University of North Carolina, Chapel Hill. It is currently FDA-approved for Luteal phase support in assisted reproductive technology (ART), Prevention of recurrent miscarriage due to luteal phase defect, Prevention of preterm birth in women with singleton pregnancy and history of preterm delivery. Also known as: micronized progesterone, Active Comparator, Cyclogest, crinone gel.
Vaginal progesterone supplements the natural hormone progesterone to support and maintain pregnancy by promoting endometrial secretion and reducing uterine contractility.
Vaginal progesterone is a small molecule that acts as a progesterone receptor agonist, classified as an agonist. It has been studied for various conditions, including preterm labor, preterm birth, threatened abortion, in vitro fertilization, and ICSI intracytoplasmic spermatozoid injection.
At a glance
| Generic name | Vaginal Progesterone |
|---|---|
| Also known as | micronized progesterone, Active Comparator, Cyclogest, crinone gel, Cyclogest 200 mg |
| Sponsor | University of North Carolina, Chapel Hill |
| Drug class | Progestin |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Obstetrics/Gynecology |
| Phase | FDA-approved |
Mechanism of action
Progesterone is a steroid hormone essential for preparing and maintaining the uterine lining (endometrium) for embryo implantation and pregnancy continuation. Vaginal administration delivers progesterone directly to the reproductive tract, achieving high local concentrations while minimizing systemic exposure. This supports luteal phase function and reduces the risk of miscarriage in women with progesterone deficiency or recurrent pregnancy loss.
Approved indications
- Luteal phase support in assisted reproductive technology (ART)
- Prevention of recurrent miscarriage due to luteal phase defect
- Prevention of preterm birth in women with singleton pregnancy and history of preterm delivery
Common side effects
- Vaginal irritation or discharge
- Headache
- Breast tenderness
- Abdominal discomfort
Key clinical trials
- Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
- Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency (PHASE3)
- Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients (NA)
- First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency (PHASE1)
- Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth (PHASE4)
- Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study
- Exogenous Progesterone as Ovulation Trigger (PHASE4)
- A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vaginal Progesterone CI brief — competitive landscape report
- Vaginal Progesterone updates RSS · CI watch RSS
- University of North Carolina, Chapel Hill portfolio CI
Frequently asked questions about Vaginal Progesterone
What is Vaginal Progesterone?
How does Vaginal Progesterone work?
What is Vaginal Progesterone used for?
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What drug class is Vaginal Progesterone in?
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What does Vaginal Progesterone target?
Related
- Drug class: All Progestin drugs
- Target: All drugs targeting Progesterone receptor
- Manufacturer: University of North Carolina, Chapel Hill — full pipeline
- Therapeutic area: All drugs in Obstetrics/Gynecology
- Indication: Drugs for Luteal phase support in assisted reproductive technology (ART)
- Indication: Drugs for Prevention of recurrent miscarriage due to luteal phase defect
- Indication: Drugs for Prevention of preterm birth in women with singleton pregnancy and history of preterm delivery
- Also known as: micronized progesterone, Active Comparator, Cyclogest, crinone gel, Cyclogest 200 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing