Effects of Isotretinoin on The Gonads and Hirsutism

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.

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Key information

Conditions

Adverse Effects of Medical Drugs Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral isotretinoin

Drug

Other names: roaccutane

Primary outcomes

Adverse Events on the Gonads and Hirsutism That are Related to Treatment

Time frame: six months

Sponsors and collaborators

Lead sponsor

Kayseri Education and Research Hospital

Other Gov

Collaborators

Kayseri Erciyes University Faculty of Medicine

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 4, 2016
Registry last updated: Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed