Thai women age 18-45 years diagnosed with PCOS with at least moderate degree of acne(IGA2-4) PCOS, acne, drosperinone only pill
Conditions
Interventions
Patients receive a drospirenone only oral contraceptive. Each pack consists of 28 tablets including 24 active hormone tablets containing drospirenone 4 mg and 4 placebo tablets without active hormones
Experimental Drug,Experimental Drug
DRSP 4 mg,DRSP 3mg with EE 20 mcg
Sponsors
Faculty of medicine, Siriraj Hospital, Mahidol university
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1 Women aged 18 to 45 years 2 Diagnosis of polycystic ovary syndrome according to the 2023 International PCOS Guideline 3 Presence of acne with Investigator Global Assessment score 2 to 4 4 Body mass index between 18 and 35 kg per m2
Exclusion criteria
Exclusion criteria: 1 Current pregnancy 2 Contraindications to hormonal contraceptive use 3 Use of exogenous estrogen-containing hormonal therapy within the past 3 months 4 History of diabetes mellitus or hypertension or cardiovascular disease 5 Current or prior history of venous thromboembolism 6 Current smoking 7 Use of oral or topical acne treatments within 2 months, or facial cosmetic/procedural treatments within 1 month prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of total acne number at 12 week after treatment numerical number,Modified Ferriman Gallway score at 12 week after treatment numerical,acne score (Investigator's Global Assessment; IGA) at 12 week after treatment scale,sebum production level at 12 week after treatment numerical,Metabolic parameters (lipid profile, 75g OGTT) at 12 week after treatment numerical ,Vaginal bleeding pattern at 12 week after treatment metric,Patient global assessment (PGA) satisfaction score at 12 week after treatment scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Ferriman Gallway score at 12 week after treatment numerical,acne score (Investigator's Global Assessment; IGA) at 12 week after treatment scale,sebum production level at 12 week after treatment numerical,Metabolic parameters (lipid profile, 75g OGTT) at 12 week after treatment numerical,Vaginal bleeding pattern at 12 week after treatment metric,Patient global assessment (PGA) satisfaction score at 12 week after treatment scale | — |
Countries
Thailand
Contacts
Public ContactPiyachat Sakunborrirak
Faculty of medicine Siriraj Hospital, Mahidol university
Outcome results
None listed