The Effects of Letrozole And Clomiphene Citrate For Induction of Ovulation In Polycystic Ovarian Syndrome(PCOS) (No)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nik Hazlina, University of Science Malaysia
ClinicalTrials.gov Identifier:
NCT01577017
First received: April 4, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Polycystic Ovarian Syndrome
Drug: Letrozole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Science Malaysia:

Primary Outcome Measures:
  • To evaluate the effectiveness of ovulation induction among PCOS patients [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    To evaluate the effectiveness of letrozole and clomiphene citrate for induction of ovulation in PCOS patients.


Secondary Outcome Measures:
  • Number of patients that can ovulate and pregnant [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 150
Study Start Date: May 2008
Study Completion Date: March 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Nik Hazlina, Associate Professor Dr, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT01577017     History of Changes
Other Study ID Numbers: PCOS- Letrozole vs Clomid
Study First Received: April 4, 2012
Last Updated: June 13, 2012
Health Authority: Malaysia: Ministry of Health

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Letrozole
Aromatase Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014