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Prontogest 400 mg vaginal pessaries
Prontogest 400 mg vaginal pessaries work by delivering progesterone to the vaginal mucosa, which helps maintain uterine quiescence and prevent preterm labor.
Prontogest 400 mg vaginal pessaries are a progesterone-based medication used primarily for the prevention of preterm labor. The drug is manufactured by Ain Shams Maternity Hospital and is not approved by the FDA. It works by maintaining uterine quiescence and preventing premature cervical ripening. While it is primarily used for its approved indication, there are no specific FDA-approved labels or detailed clinical trial data available. The safety profile includes common side effects such as vaginal discharge and itching, and it is contraindicated in women with known hypersensitivity to progesterone. The drug is not commercially available in the United States, and there is limited information on its revenue and market performance.
At a glance
| Generic name | Prontogest 400 mg vaginal pessaries |
|---|---|
| Also known as | placebo vaginal pessaries |
| Sponsor | Ain Shams Maternity Hospital |
| Drug class | Progesterone |
| Target | Uterine smooth muscle and cervical tissue |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Progesterone is a hormone that plays a crucial role in maintaining pregnancy by reducing uterine contractility and promoting cervical integrity.
Approved indications
Common side effects
- Vaginal discharge
- Vaginal itching
Key clinical trials
- Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles (NA)
- Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM (PHASE4)
- Omega 3 Plus Vaginal Progesterone on Birth Weight of Constitutionally Small for Gestational Age Fetuses (NA)
- Timing of Initiation of Luteal Phase Support in Poor Responders Undergoing IVF/ICSI (PHASE4)
- Progesterone in Patients With Placenta Previa (PHASE2)
- Progesterone and Doppler in Recurrent Abortion (PHASE4)
- Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth (PHASE2, 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:
- Prontogest 400 mg vaginal pessaries CI brief — competitive landscape report
- Prontogest 400 mg vaginal pessaries updates RSS · CI watch RSS
- Ain Shams Maternity Hospital portfolio CI