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Metformin plus clomiphene citrate
Metformin reduces hepatic glucose production and improves insulin sensitivity, while clomiphene citrate acts as a selective estrogen receptor modulator to stimulate ovulation and restore reproductive function.
Metformin improves insulin sensitivity and reduces hepatic glucose production, while clomiphene citrate acts as a selective estrogen receptor modulator to stimulate ovulation. Used for Anovulation and infertility in polycystic ovary syndrome (PCOS), Ovulatory dysfunction in insulin-resistant women.
At a glance
| Generic name | Metformin plus clomiphene citrate |
|---|---|
| Sponsor | University Magna Graecia |
| Drug class | Combination therapy: biguanide + selective estrogen receptor modulator (SERM) |
| Target | Insulin signaling pathway (metformin); estrogen receptor (clomiphene citrate) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Endocrinology / Fertility |
| Phase | FDA-approved |
Mechanism of action
This combination targets both metabolic and reproductive dysfunction, commonly seen in polycystic ovary syndrome (PCOS). Metformin decreases insulin resistance and lowers androgen levels, creating a more favorable hormonal environment. Clomiphene citrate blocks negative feedback on the hypothalamic-pituitary-ovarian axis, promoting follicle-stimulating hormone (FSH) release and ovulation.
Approved indications
- Polycystic ovary syndrome (PCOS) with anovulation and infertility
- Insulin resistance with reproductive dysfunction
Common side effects
- Gastrointestinal disturbance (metformin)
- Hot flashes (clomiphene)
- Ovarian hyperstimulation syndrome (clomiphene)
- Visual disturbances (clomiphene)
- Headache
Key clinical trials
- Metformine and CC Compared With Placebo and CC for Induction Ovulation in PCOS Patients With Insulin Resistant (PHASE2)
- Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome (PHASE3)
- Different Induction Protocols in PCOS After Clomiphene Citrate Failed Pregnancy in Non-IVF Cycles (PHASE4)
- Pioglitazone Versus Metformin as First Treatment in Infertile Women With Polycystic Ovary Syndrome (EARLY_PHASE1)
- Added Value of N Acetyle Cysteine to Clomiphene Citrate in PCO (NA)
- Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients (PHASE2)
- Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate (PHASE2)
- Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility (EARLY_PHASE1)
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:
- Metformin plus clomiphene citrate CI brief — competitive landscape report
- Metformin plus clomiphene citrate updates RSS · CI watch RSS
- University Magna Graecia portfolio CI