Last reviewed 2026-05-23 · How we verify

Vaginal Progesteron

Vaginal Progesteron is a Progestin Small molecule drug developed by Omar Mamdouh Shaaban. It is currently FDA-approved for Luteal phase support in assisted reproductive technology (ART), Prevention of preterm birth in singleton pregnancies with a history of preterm delivery, Recurrent pregnancy loss prevention. Also known as: Progesterone.

Vaginal progesterone delivers the hormone progesterone directly to the reproductive tract to support luteal phase function and maintain early pregnancy.

Vaginal progesterone is used to treat conditions such as infertility, ovarian hyperstimulation syndrome (OHSS), preterm birth, twin pregnancy, and short cervix. It works by acting as a progesterone receptor agonist, stimulating the progesterone receptor to promote implantation and maintenance of pregnancy.

At a glance

Mechanism of action

Progesterone is a naturally occurring steroid hormone essential for preparing and maintaining the uterine endometrium for implantation and early pregnancy. Vaginal administration provides local and systemic progesterone levels to support the luteal phase, reduce miscarriage risk in certain populations, and prevent preterm labor. The vaginal route offers improved bioavailability and reduced hepatic metabolism compared to oral formulations.

Approved indications

• Luteal phase support in assisted reproductive technology (ART)
• Prevention of preterm birth in singleton pregnancies with a history of preterm delivery
• Recurrent pregnancy loss prevention

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)
• 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)
• Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Vaginal Progesteron CI brief — competitive landscape report
• Vaginal Progesteron updates RSS · CI watch RSS
• Omar Mamdouh Shaaban portfolio CI

Frequently asked questions about Vaginal Progesteron

Related

• Drug class: All Progestin drugs
• Target: All drugs targeting Progesterone receptor
• Manufacturer: Omar Mamdouh Shaaban — 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 preterm birth in singleton pregnancies with a history of preterm delivery
• Indication: Drugs for Recurrent pregnancy loss prevention
• Also known as: Progesterone

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing