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Oral micronized progesterone
Oral micronized progesterone acts as a progestin that binds to progesterone receptors in the uterus and other reproductive tissues to regulate the menstrual cycle and support pregnancy.
Oral micronized progesterone acts as a progestin that binds to progesterone receptors in the uterus and other reproductive tissues to regulate the menstrual cycle and support pregnancy. Used for Luteal phase support in assisted reproductive technology (ART), Threatened or recurrent miscarriage prevention, Hormone replacement therapy in menopause.
At a glance
| Generic name | Oral micronized progesterone |
|---|---|
| Also known as | Prometrium, Utrogestan, Progesterone, progesterone, P4 |
| Sponsor | University of British Columbia |
| Drug class | Progestin |
| Target | Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Obstetrics/Gynecology |
| Phase | FDA-approved |
Mechanism of action
Progesterone is a naturally occurring steroid hormone that exerts its effects by binding to intracellular progesterone receptors (PR-A and PR-B). In the endometrium, it transforms the proliferative tissue into a secretory state, essential for implantation and maintenance of pregnancy. Micronization increases the bioavailability of the oral formulation, allowing adequate systemic absorption without first-pass hepatic metabolism.
Approved indications
- Luteal phase support in assisted reproductive technology (ART)
- Threatened or recurrent miscarriage prevention
- Hormone replacement therapy in menopause
Common side effects
- Drowsiness or dizziness
- Headache
- Breast tenderness
- Abdominal bloating
- Mood changes
Key clinical trials
- Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation. (PHASE4)
- Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy (NA)
- Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency (PHASE3)
- No More Sleepless Nights in Perimenopause (PHASE4)
- Chinese Herbal Medicine (New "Shoutai Wan") and/or Oral Progesterone Intervention Trial for Threatened Miscarriage (PHASE3)
- Role of Estrogen on Skeletal Outcomes in FHA (PHASE2)
- Progesterone in Gender Affirming Hormone Therapy Study (PHASE2)
- Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (PHASE4)
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:
- Oral micronized progesterone CI brief — competitive landscape report
- Oral micronized progesterone updates RSS · CI watch RSS
- University of British Columbia portfolio CI