Effects of Isotretinoin on The Gonads and Hirsutism
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|ClinicalTrials.gov Identifier: NCT02855138|
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : August 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Effects of Medical Drugs||Drug: oral isotretinoin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Oral Isotretinoin in Women With Acne and Polycystic Ovary Syndrome|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||June 2016|
Active Comparator: study group
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
Other Name: roaccutane
No Intervention: control group
The control group of this study was pretreatment period of the same volunteer patients.
- Adverse Events on the Gonads and Hirsutism That are Related to Treatment [ Time Frame: six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855138
|Principal Investigator:||GÖKHAN ACMAZ||Kayseri Education and Research Hospital|