Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: Letrozole; Drug: Clomiphene citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00610077

LET/SPIL/03/06

Details and patient eligibility

About

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.

Full description

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

Enrollment: 55 patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females with anovulatory infertility 20-38 years of age.
• Diagnosis of anovulatory infertility as established by standard criteria.
• Normal Pelvic USG and bilateral tubal patency
• Willingness and giving written Informed Consent.

Exclusion criteria

• Uterine and adnexal pathology e.g. leiomyomata
• Ovarian cyst
• Hyperprolactinaemia
• Hyperthyroidism or Hypothyroidism*
• FSH >9mIU/ml (during early follicular phase).* (As per Chemoluminescence method)
• Previous surgery related to genital tract as per history
• Appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy
• Impaired hepatic /renal function
• Diabetes mellitus/Random blood sugar- > 140mg/dl
• Drugs likely to interfere with ovulation
• Alcohol intake as per history
• History of hypersensitivity to the study drug or to its excipients
• Planned travel outside the study area for a substantial portion (>5 days) of the study period by potential participants
• Lack of willingness to give informed written consent
• Participation in any clinical study within the preceding 1 month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

1

Experimental group

Description:

Letrozole

Treatment:

Drug: Letrozole

2

Active Comparator group

Description:

Clomiphene citrate

Treatment:

Drug: Clomiphene citrate