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

NCT01577017 | Completed Phase 3 DMC

• 1 other identifier: PCOS- Letrozole vs Clomid
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovarian Syndrome

Keywords

ovulation induction, clomiphene citrate, letrozole

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of ovulation induction among PCOS patients

  To evaluate the effectiveness of letrozole and clomiphene citrate for induction of ovulation in PCOS patients.

  6 weeks

Secondary Outcomes (1)

• Number of patients that can ovulate and pregnant

  6 weeks

Study Arms (1)

Letrozole

EXPERIMENTAL

Group L will be assigned with Letrozole 5 mg on night on day 5 to day 9 of the cycle

Drug: Letrozole

Interventions

Letrozole DRUG

Women in group L will be assigned with Letrozole on night at day 5 to day 9 of the cycle

Also known as: Femara (Aromatase Inhibitor)

Letrozole

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nik Hazlina: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Dr

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 13, 2012
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: March 1, 2012
• Last Updated: June 14, 2012

Record last verified: 2012-06