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
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Letrozole
Drug: Clomiphene citrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.

Resource links provided by NLM:


Further study details as provided by Sun Pharmaceutical Industries Limited:

Primary Outcome Measures:
  • Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG). [ Time Frame: 3 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: December 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Letrozole
Drug: Letrozole
Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
Other Name: Letroz
Active Comparator: 2
Clomiphene citrate
Drug: Clomiphene citrate
Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
Other Name: Ferotab

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610077

Locations
India
IVF Centre, Chembur,
Mumbai-, Maharashtra, India, 400071
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Investigators
Principal Investigator: Mandakini Parihar, M.D., D.G.O. Director, IVF Centre, Chembur
  More Information

No publications provided

Responsible Party: Medical Advisor, Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT00610077     History of Changes
Other Study ID Numbers: LET/SPIL/03/06
Study First Received: January 24, 2008
Last Updated: February 6, 2008
Health Authority: India: Drugs Controller General of India

Keywords provided by Sun Pharmaceutical Industries Limited:
Letrozole
Clomiphene citrate
Anovulatory infertility
Ovulation induction

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Letrozole
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014