Effects of Isotretinoin on The Gonads and Hirsutism

Phase 4

Completed

• Conditions: Adverse Effects of Medical Drugs
• Interventions: Drug: oral isotretinoin

• Registration Number: NCT02855138
• Lead Sponsor: Kayseri Education and Research Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-03
• Study Completion: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• consisted of 40 volunteers women with PCOS (aged 18- 40 years, BMI, 18-44kg/m2) who attended our obstetrics and gynecology clinic for the treatment menstrual irregularities and hirsutism

Exclusion Criteria

• 1)presence of any dermatologic disorder besides acne 2) presence of any systemic disease 3) exposure to any systemic treatment in the last three months that could alter ovarian reserve 4) pregnancy or lactation 5) infection diseases 6) use of antidepressants, steroidal hormone drugs, mood stabilizers, caffeine, alcohol, or tobacco 7) histories of abdominal surgery for endometriosis or ovarian surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	oral isotretinoin	The study group consisted of 40 volunteers women with PCOS (aged 18- 40 years, BMI, 18-44kg/m2) who attended the obstetrics and gynecology clinic for the treatment of menstrual irregularities and hirsutism.The patients were treated with 0.6-0.8 mg/kg oral isotretinoin up to a total dose of 120-150 mg/kg. Treatment was started at 20 mg/day and gradually increased to the maximum of 40 mg/day. The patients were monitored monthly during isotretinoin treatment.

Primary Outcome Measures

Name	Time	Method
Adverse Events on the Gonads and Hirsutism That are Related to Treatment	six months