Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

This study has been completed.
Sponsor:
Information provided by:
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT00610077
First received: January 24, 2008
Last updated: February 6, 2008
Last verified: January 2008

January 24, 2008
February 6, 2008
December 2004
July 2006   (final data collection date for primary outcome measure)
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG). [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610077 on ClinicalTrials.gov Archive Site
  • Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography. [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 3 cycles ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Drug: Letrozole
    Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
    Other Name: Letroz
  • Drug: Clomiphene citrate
    Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
    Other Name: Ferotab
  • Experimental: 1
    Letrozole
    Intervention: Drug: Letrozole
  • Active Comparator: 2
    Clomiphene citrate
    Intervention: Drug: Clomiphene citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Female
20 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00610077
LET/SPIL/03/06
No
Medical Advisor, Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited
Not Provided
Principal Investigator: Mandakini Parihar, M.D., D.G.O. Director, IVF Centre, Chembur
Sun Pharmaceutical Industries Limited
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP