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Comparison of oral contraceptives including Contrasmine, Etisterone and Desoceptive with Ovustop-L (LD) on clinical, biochemical and metabolic findings, and quality of life in women with polycystic ovary syndrome.

A Randomized cross-over clinical trial to assess the effectiveness of oral contraceptives including Contrasmine, Etisterone and Desoceptive with Ovustop-L (LD) on clinical, biochemical and metabolic findings, and quality of life in women with polycystic ovary syndrome.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201702071281N2
Enrollment
200
Registered
2017-02-21
Start date
2017-02-19
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Polycystic ovary syndrome. Sclerocystic ovary syndrome Stein-Leventhal syndrome

Interventions

Intervention 1: A. Outcome measurement, 6 months of treatment with Ovustop-L, outcome measurement in the end of third and six months of treatment, a washout period for 6 weeks, Outcome measurement, th
Treatment - Drugs
A. Outcome measurement, 6 months of treatment with Ovustop-L, outcome measurement in the end of third and six months of treatment, a washout period for 6 weeks, Outcome measurement, the second treatme
B. Outcome measurement, 6 months of treatment with Contrasmine, outcome measurement in the end of third and six months of treatment, a washout period for 6 weeks, Outcome measurement, the second treat
C. Outcome measurement, 6 months of treatment with Ovustop-L, outcome measurement in the end of third and six months of treatment, a washout period for 6 weeks, Outcome measurement, the second treatme
D. Outcome measurement, 6 months of treatment with Etisterone, outcome measurement in the end of third and six months of treatment, a washout period for 6 weeks, Outcome measurement, the second treatm
E. Outcome measurement, 6 months of treatment with Ovustop-L, outcome measurement in the end of third and six months of treatment, a washout period for 6 weeks, Outcome measurement, the second treatme
F. Outcome measurement, 6 months of treatment with Desoceptive, outcome measurement in the end of third and six months of treatment, a washout period for 6 weeks, Outcome measurement, the second treat

Sponsors

Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, I
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: Existent of diagnostic criteria for polycystic ovary syndrome based on Androgen Excess and PCOS Society (AES), Lack of pregnancy diagnosis and tendency to it for a year or more, lack of using hormonal, anti-androgens or sensitizers drugs at least 3 months before the study, Failure to detect other causes of hyperandrogenism, Not having chronic medical conditions, high and severe blood pressure, recent surgery or known cancer, 6- Not smoking and non-obesity. Exclusion criteria: Not adherence to prescribed medications for more than two months, detection of chronic medical disorders, Appearing the serious effects such as thrombosis contraceptive.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Free Androgen Index (FAI). Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: According to the formula of total testosterone (nmol/ L)) x 100 /sex hormone-binding globulin).

Secondary

MeasureTime frame
Hirsutism. Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: Ferriman- Galwey scoring system.;Body mass index (BMI). Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: kg/m2.;Acne. Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: Wang criteria.;Alopecia. Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: Ludwig criteria.;Menstruation cycles pattern. Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: questionnaire.;Insulin resistance. Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: Electrochemilumniscen immuno assay.;Fasting blood sugar (FBS). Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: Enzymatic colorimetric.;(TG) triglyceride. Timepoint: (Before treatment, 3 months after first treatment, 6 months after first treatment, after wash-out, 3 months after second treatment, 6 months after second treatment). Method of measurement: Calorimetric.;Total Cholesterol. Timepoint: (Before treatment, 3 months after first treatment, 6 months afte

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh Ramezani Tehrani

Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences ShahidBeheshti

ramezani@endocrine.ac.ir+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 26, 2026