NCT00610077

Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.

Detailed description

MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Letrozole	Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
DRUG	Clomiphene citrate	Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2008-02-07
• Last updated: 2008-02-07

Locations

1 site across 1 country: India