Effects of Isotretinoin on The Gonads and Hirsutism

Adverse Effects of Medical Drugs Clinical Trial

Official title: The Effects of Oral Isotretinoin in Women With Acne and Polycystic Ovary Syndrome

Status Completed

Clinical Trial Summary

The investigators consider that there are some rising concerns about the use of isotretinoin by women of reproductive age with depleted ovarian reserve, hence it is important to detect the effect of isotretinoin on ovarian reserve.

There has not been a well-designed study evaluating its effects on the human ovarian reserve, hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS). For this reasons, this study was administered to determine whether there is an effect of isotretinoin on the gonads and hirsutism in women with acne and PCOS.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Adverse Effects of Medical Drugs

• NCT number: NCT02855138
• Study type: Interventional
• Source: Kayseri Education and Research Hospital
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Completion date: June 2016