Adverse Effects of Medical Drugs
Conditions
Keywords
isotretinoin, PCOS, acne vulgaris
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.
Interventions
Sponsors
Kayseri Erciyes University Faculty of Medicine
Kayseri Education and Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events on the Gonads and Hirsutism That are Related to Treatment | six months |
Outcome results
None listed