Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
This study has been completed.
Sponsor:
Sun Pharmaceutical Industries Limited
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
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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
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 Letrozole Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating 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 May 21, 2013