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The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS)

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: NCT01577017
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
Nik Hazlina, University of Science Malaysia

Brief Summary:
As both medications i.e. CC and letrozole have been shown to be effective in inducing ovulation in PCOS patients, this study was performed in order to evaluate which regime (whether CC or letrozole) is the best to be used as the first line treatment for PCOS patients with infertility for local population. The best regime will therefore could be included in the protocol of management of infertility patients with PCOS so that the quality of patients' care could be improved.

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Drug: Letrozole Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study On The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS)
Study Start Date : May 2008
Primary Completion Date : May 2009
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Letrozole
Group L will be assigned with Letrozole 5 mg on night on day 5 to day 9 of the cycle
Drug: Letrozole
Women in group L will be assigned with Letrozole on night at day 5 to day 9 of the cycle
Other Name: Femara (Aromatase Inhibitor)

Primary Outcome Measures :
  1. To evaluate the effectiveness of ovulation induction among PCOS patients [ Time Frame: 6 weeks ]
    To evaluate the effectiveness of letrozole and clomiphene citrate for induction of ovulation in PCOS patients.

Secondary Outcome Measures :
  1. Number of patients that can ovulate and pregnant [ Time Frame: 6 weeks ]
    i. ovulation rate among PCOS patients with letrozole and CC ii. endometrial thickness among patients with letrozole and CC iii. number of pregnancy between letrozole and CC iv. associated factors that can influence the effectiveness of the treatment found in age, body weight, duration of marriage, duration of infertility and types of infertility either primary or secondary among PCOS patients.

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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion criteria

  • Age > 18 years but < 40 years old
  • Was diagnosed PCOS
  • Normal husband's seminal fluid analysis (SFA)

Exclusion criteria :

  • Not having medical problems eg- renal disease, tyhroid disorder, hyperprolactinemia, liver disease.
  • Other causes of anovulatory infertility

Responsible Party: Nik Hazlina, Associate Professor Dr, University of Science Malaysia Identifier: NCT01577017     History of Changes
Other Study ID Numbers: PCOS- Letrozole vs Clomid
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Nik Hazlina, University of Science Malaysia:
ovulation induction, clomiphene citrate, letrozole

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Aromatase Inhibitors
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs