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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01577017
Other study ID # PCOS- Letrozole vs Clomid
Secondary ID
Status Completed
Phase Phase 3
First received April 4, 2012
Last updated June 13, 2012
Start date May 2008
Est. completion date March 2012

Study information

Verified date June 2012
Source University of Science Malaysia
Contact n/a
Is FDA regulated No
Health authority Malaysia: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nik Hazlina

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Number of patients that can ovulate and pregnant 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. 6 weeks Yes
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