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Effects of Isotretinoin on The Gonads and Hirsutism

K

Kayseri Education and Research Hospital

Status and phase

Completed
Phase 4

Conditions

Adverse Effects of Medical Drugs

Treatments

Drug: oral isotretinoin

Study type

Interventional

Funder types

Other

Identifiers

NCT02855138
2016/358

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

study group
Active Comparator group
Description:
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.
Treatment:
Drug: oral isotretinoin
control group
No Intervention group
Description:
The control group of this study was pretreatment period of the same volunteer patients.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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