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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855138
• Other study ID #: 2016/358
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2016
• Last updated: August 4, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

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

Intervention

Drug:
• oral isotretinoin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital	Kayseri Erciyes University Faculty of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events on the Gonads and Hirsutism That are Related to Treatment		six months	No