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Provera 10 mg.
Provera 10 mg. is a Progestin (synthetic progesterone) Small molecule drug developed by Instituto Valenciano de Infertilidad, IVI VALENCIA. It is currently in Phase 3 development for Contraception, Hormone replacement therapy, Treatment of abnormal uterine bleeding.
Provera (medroxyprogesterone acetate) is a synthetic progestin that suppresses gonadotropin secretion and inhibits ovulation by acting on the hypothalamic-pituitary-ovarian axis.
Provera 10 mg is a medication that contains the progestin medroxyprogesterone 17-acetate, which has been studied in clinical trials for various conditions including Polycystic Ovary Syndrome, Infertility, Dysfunctional Uterine Bleeding, Endometrial Cancer, and IVF. It is used as an intervention in fertility treatments, including those involving clomiphene citrate, to optimize fertility outcomes in women with Polycystic Ovary Syndrome.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Provera 10 mg. |
|---|---|
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA |
| Drug class | Progestin (synthetic progesterone) |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Reproductive Health |
| Phase | Phase 3 |
Mechanism of action
Medroxyprogesterone acetate is a long-acting progestin that prevents pregnancy through multiple mechanisms: it thickens cervical mucus to impede sperm transport, alters the endometrium to prevent implantation, and most importantly, suppresses the luteinizing hormone (LH) surge required for ovulation. The 10 mg formulation is typically used for contraceptive or hormone replacement purposes.
Approved indications
- Contraception
- Hormone replacement therapy
- Treatment of abnormal uterine bleeding
Common side effects
- Irregular bleeding or amenorrhea
- Weight gain
- Headache
- Breast tenderness
- Mood changes
Key clinical trials
- SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer
- Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification (PHASE2, PHASE3)
- Intrauterine Stent Placement Following Hysteroscopic Septum Resection (NA)
- Aciclovir Versus Placebo for HSV-2 Meningitis (PHASE4)
- Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency (NA)
- Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer (PHASE4)
- Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features (PHASE2, PHASE3)
- Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A. (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:
- Provera 10 mg. CI brief — competitive landscape report
- Provera 10 mg. updates RSS · CI watch RSS
- Instituto Valenciano de Infertilidad, IVI VALENCIA portfolio CI
Frequently asked questions about Provera 10 mg.
What is Provera 10 mg.?
How does Provera 10 mg. work?
What is Provera 10 mg. used for?
Who makes Provera 10 mg.?
What drug class is Provera 10 mg. in?
What development phase is Provera 10 mg. in?
What are the side effects of Provera 10 mg.?
What does Provera 10 mg. target?
Related
- Drug class: All Progestin (synthetic progesterone) drugs
- Target: All drugs targeting Progesterone receptor
- Manufacturer: Instituto Valenciano de Infertilidad, IVI VALENCIA — full pipeline
- Therapeutic area: All drugs in Contraception / Reproductive Health
- Indication: Drugs for Contraception
- Indication: Drugs for Hormone replacement therapy
- Indication: Drugs for Treatment of abnormal uterine bleeding
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing