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Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome


N/A
20 Years
36 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome


Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before
stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis
Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all
patients in the combined metformin-CC group) received metformin HCl [Cidophage®; Chemical
Industries Development(CID), Cairo, Egypt], 500 mg three times daily for 6-8 weeks. Then
after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals,
Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment
for three successive cycles using the same protocol. Metformin was stopped only when
pregnancy was documented.


Inclusion Criteria:



- CC resistant PCOS

Exclusion Criteria:

- Congenital adrenal hyperplasia

- Cushing syndrome

- Androgen secreting tumors

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).

Safety Issue:

No

Principal Investigator

Hatem Abu Hashim, MD. MRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mansoura University Hospitals

Authority:

Egypt: Institutional Review Board

Study ID:

MU- 059

NCT ID:

NCT00911313

Start Date:

June 2006

Completion Date:

January 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovary syndrome
  • clomiphene resistance
  • letrozole
  • Polycystic Ovary Syndrome

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