Effects of Isotretinoin on The Gonads and Hirsutism

Study Overview
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Brief Summary
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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.

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

Conditions
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Adverse Effects of Medical Drugs

Intervention / Treatment
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* Drug: oral isotretinoin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>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. | Drug: oral isotretinoin<br> <br> * Other names: roaccutane;|
| No Intervention: control group<br>The control group of this study was pretreatment period of the same volunteer patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events on the Gonads and Hirsutism That are Related to Treatment |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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isotretinoin, PCOS, acne vulgaris