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Metformin + Clomiphene
Metformin improves insulin sensitivity and reduces hepatic glucose production, while clomiphene stimulates ovulation by blocking estrogen feedback on the hypothalamus and pituitary.
Metformin improves insulin sensitivity and reduces hepatic glucose production, while clomiphene stimulates ovulation by blocking estrogen feedback on the hypothalamus and pituitary. Used for Polycystic ovary syndrome (PCOS) with anovulation and infertility, Clomiphene-resistant PCOS.
At a glance
| Generic name | Metformin + Clomiphene |
|---|---|
| Sponsor | University of Auckland, New Zealand |
| Drug class | Combination therapy: biguanide + selective estrogen receptor modulator (SERM) |
| Target | Metformin: AMP-activated protein kinase (AMPK); Clomiphene: estrogen receptor (ER) |
| Modality | Small molecule |
| Therapeutic area | Reproductive endocrinology / Fertility |
| Phase | FDA-approved |
Mechanism of action
This combination targets polycystic ovary syndrome (PCOS) and infertility by addressing both the metabolic dysfunction (via metformin's effects on insulin resistance) and the reproductive dysfunction (via clomiphene's ovulatory stimulation). Metformin reduces hyperinsulinemia and androgen levels, while clomiphene acts as a selective estrogen receptor modulator to promote follicle-stimulating hormone (FSH) secretion and ovulation.
Approved indications
- Polycystic ovary syndrome (PCOS) with anovulation and infertility
- Clomiphene-resistant PCOS
Common side effects
- Gastrointestinal disturbance (metformin)
- Hot flushes (clomiphene)
- Ovarian hyperstimulation syndrome (clomiphene)
- Visual disturbances (clomiphene)
- Headache
- Nausea
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)
- Vitamin D for Polycystic Ovary Syndrome Clomiphene Resistant Women (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:
- Metformin + Clomiphene CI brief — competitive landscape report
- Metformin + Clomiphene updates RSS · CI watch RSS
- University of Auckland, New Zealand portfolio CI