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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
Sponsor:
Collaborator:
Kayseri Erciyes University Faculty of Medicine
Information provided by (Responsible Party):
Gökhan Açmaz, 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.


Condition or disease Intervention/treatment Phase
Adverse Effects of Medical Drugs Drug: oral isotretinoin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Adverse Events on the Gonads and Hirsutism That are Related to Treatment [ Time Frame: six months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Kayseri Education and Research Hospital
Kayseri Erciyes University Faculty of Medicine
Investigators
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Principal Investigator: GÖKHAN ACMAZ Kayseri Education and Research Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gökhan Açmaz, obstetrics and gynecology, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02855138     History of Changes
Other Study ID Numbers: 2016/358
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: July 2016
Keywords provided by Gökhan Açmaz, Kayseri Education and Research Hospital:
isotretinoin
PCOS
acne vulgaris
Additional relevant MeSH terms:
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Isotretinoin
Dermatologic Agents