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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2006

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

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Letrozole
• Active Comparator: 2
  • Clomiphene citrate

Primary Measures

• Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
  • Time Frame: 3 cycles
    Safety Issue?: No

Secondary Measures

• Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.
  • Time Frame: 3 cycles
    Safety Issue?: No
• Safety
  • Time Frame: 3 cycles
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 38 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sun Pharmaceutical Industries Limited

Overall Clinical Trial Officials and Contacts

Mandakini Parihar, M.D., D.G.O. Principal Investigator Director, IVF Centre, Chembur  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00610077

Study ID Number: LET/SPIL/03/06

ClinicalTrials.gov Identifier: NCT00610077

Health Authority: India: Drugs Controller General of India