Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00911313

Enrollment

250

Registered

2009-06-01

Start date

2006-06-30

Completion date

2009-01-31

Last updated

2009-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome, clomiphene resistance, letrozole

Brief summary

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.

Detailed description

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.

Interventions

DRUGLetrozole tablets (Femara; Novartis Pharma, Switzerland)

2.5 mg letrozole daily from day 3 of the menses for 5 days

DRUGmetformin HCl (Cidophage®; CID,Cairo, Egypt)

metformin HCl 1500 daily for 6-8 weeks

DRUGCC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)

150 mg CC for 5 days starting from day 3 of menstruation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 36 Years

Healthy volunteers

Inclusion criteria

* CC resistant PCOS

Exclusion criteria

* Congenital adrenal hyperplasia * Cushing syndrome * Androgen secreting tumors

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
The occurrence of pregnancy and miscarriage.	—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026