Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610077
• Other study ID #: LET/SPIL/03/06
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2008
• Last updated: February 6, 2008
• Start date: December 2004
• Est. completion date: July 2006

Study information

• Verified date: January 2008
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Letrozole
Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
• Clomiphene citrate
Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles

Locations

Country	Name	City	State
India	IVF Centre, Chembur,	Mumbai-	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).		3 cycles	No
Secondary	Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.		3 cycles	No
Secondary	Safety		3 cycles	Yes