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Trial record 8 of 165 for:    ISOTRETINOIN

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

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date August 5, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
Adverse Events on the Gonads and Hirsutism That are Related to Treatment [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Adverse Effects of Isotretinoin on the Gonads and Hirsutism [ Time Frame: six months ]
Change History Complete list of historical versions of study NCT02855138 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Isotretinoin on The Gonads and Hirsutism
Official Title  ICMJE The Effects of Oral Isotretinoin in Women With Acne and Polycystic Ovary Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Adverse Effects of Medical Drugs
Intervention  ICMJE Drug: oral isotretinoin
Other Name: roaccutane
Study Arms  ICMJE
  • 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.
    Intervention: Drug: oral isotretinoin
  • No Intervention: control group
    The control group of this study was pretreatment period of the same volunteer patients.
Publications * Acmaz G, Cınar L, Acmaz B, Aksoy H, Kafadar YT, Madendag Y, Ozdemir F, Sahin E, Muderris I. The Effects of Oral Isotretinoin in Women with Acne and Polycystic Ovary Syndrome. Biomed Res Int. 2019 Apr 7;2019:2513067. doi: 10.1155/2019/2513067. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02855138
Other Study ID Numbers  ICMJE 2016/358
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gökhan Açmaz, Kayseri Education and Research Hospital
Study Sponsor  ICMJE Kayseri Education and Research Hospital
Collaborators  ICMJE Kayseri Erciyes University Faculty of Medicine
Investigators  ICMJE
Principal Investigator: GÖKHAN ACMAZ Kayseri Education and Research Hospital
PRS Account Kayseri Education and Research Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP