Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00610077
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : February 7, 2008
Information provided by:
Sun Pharmaceutical Industries Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Letrozole Drug: Clomiphene citrate Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG). [ Time Frame: 3 cycles ]

Secondary Outcome Measures :
  1. Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography. [ Time Frame: 3 cycles ]
  2. Safety [ Time Frame: 3 cycles ]

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00610077

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

Responsible Party: Medical Advisor, Sun Pharmaceutical Industries Limited Identifier: NCT00610077     History of Changes
Other Study ID Numbers: LET/SPIL/03/06
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: February 7, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators