Skip to content

A Randomized, Crossover Study of Medroxyprogesterone Acetate and Diane-35 on Polycystic Ovarian Syndrome Adolescents

A Randomized, Crossover Study of Medroxyprogesterone Acetate and Diane-35 on Polycystic Ovarian Syndrome Adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000699
Enrollment
Unknown
Registered
2007-08-14
Start date
2007-08-22
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovarian Syndrome

Interventions

Two Groups:Group 1 oral (medroxyprogesterone acetate) MPA 10 mg daily for 10 days for every month for the first 4 months, followed by a washout period of 4 months, and then diane-35 one tablet daily f

Sponsors

None listed

Eligibility

Sex/Gender
Male
Age
14 Years to 19 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients aged 14 to 19 and diagnosed PCOS in the Gynaecology clinics of AHNH and PWH. The diagnosis of PCOS is based on the Rotterdam consensus on diagnostic criteria for PCOS; that is, at least 2 out of 3 of the following criteria: 1. Oligo- and / or anovulation; 2. Clinical and / or biochemical signs of hyperandrogenism; 3. Ultrasound appearance of polycystic ovaries; and exclusion of other aetiologies.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: 1. patient who has fertility wish; 2. confirmed concomitant diabetics mellitus which may need other medical treatment for PCOS; 3. significant liver impairment or other medical condition that is contraindicated for MPA or diane-35; and 4. previous use of hormonal treatment in the past 4 months.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the psychological well being of the subjects on the different treatments, using a standard questionnaire 36-item Short Form Health Survey (SF-36) and a client satisfaction questionnaire. They will be assessed during every visit (ie at baseline, 4 month, 8 month & 12 month of study);

Secondary

MeasureTime frame
All of the following will be assessed or measured during every visit (ie at baseline, 4 month, 8 month & 12 month of study) 1. Menstrual pattern and any abnormal bleeding throughout the study period.;2. Clinical parameters including body mass index, blood pressure, waist-to-hip circumference ratio, scoring on acne and hirsutism.;3. Hormonal profile by measurements of serum concentrations of luteinizing hormone, follicular stimulating hormone, oestradiol, testosterone, sex hormone binding globulin, and androstenedione.;

Countries

China

Contacts

Public ContactDr Chan Shing Chee, Symphorosa
symphorosa@cuhk.edu.hk+852 2632 2583

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026