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.
Oral contraceptives (OC) are the most common treatment for patients with polycystic ovary syndrome (PCOS) who do not seek pregnancy. Some studies have raised concern regarding the potential adverse cardiovascular and metabolic effects of OC in women with PCOS. Despite claims of better efficacy and fewer side effects the newer contraceptive compounds than Ovustop-L (LD), there are no strong clinical trials to confirm this effects. The aim of this randomized cross-over trial clinical was to compare 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. Sampling method will be convenience or continues. The examinations and laboratory tests will be done in the Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Patients diagnosed based on Androgen Excess and PCOS Society (AES) criteria will be studied. In the present study, we will have 6 arms or group treatments that will be randomly assigned to each of the groups. Each patient will alternately be treated with Ovustop-L (LD) for a six-month period and a six month period with one of the other types of contraceptive treatment. A wash-out a period of 6 weeks will be considered between the two treatments. Outcomes will be evaluated before and after each treatment. Outcomes measured will be included clinical, hormonal and metabolic profiles and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702071281N2
Registration date:2017-02-21, 1395/12/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-21, 1395/12/03
Registrant information
Name
Fahimeh Ramezani Tehrani
Name of organization / entity
Research Institute for Endocrine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
ramezani@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
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.
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, I
(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 outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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
8
Description
(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
9
Description
Total Cholesterol
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
10
Description
total testosterone (TT)
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
enzyme immunoassay
11
Description
Dehydroepiandrosterone sulfat
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
enzyme immunoassay
12
Description
Sex hormone-binding globulin (SHBG)
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
Immunoradiometric assay
13
Description
quality of life
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
Likert rating lifestyle questionnaire
Intervention groups
1
Description
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 treatment with Contrasmine for 6 months, outcome measurement in the end of third and six months of treatment.
Category
Treatment - Drugs
2
Description
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 treatment with Ovustop-L for 6 months, outcome measurement in the end of third and six months of treatment.
Category
Treatment - Drugs
3
Description
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 treatment with Etisterone for 6 months, outcome measurement in the end of third and six months of treatment.
Category
Treatment - Drugs
4
Description
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 treatment with Ovustop-L for 6 months, outcome measurement in the end of third and six months of treatment.
Category
Treatment - Drugs
5
Description
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 treatment with Desoceptive for 6 months, outcome measurement in the end of third and six months of treatment.
Category
Treatment - Drugs
6
Description
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 treatment with Ovustop-L for 6 months, outcome measurement in the end of third and six months of treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences,
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
(Health Houses (district 10
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
(Health Houses (district 16
Full name of responsible person
Street address
City
Tehran
4
Recruitment center
Name of recruitment center
Health Houses (district 2)
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, I
Full name of responsible person
Fahimeh Ramezani Tehrani
Street address
24 Parvaneh, Yaman Street, Velenjak, P.O.Box:19395-4763, Tehran Iran.f
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, I
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences ShahidBeheshti
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
Professor
Other areas of specialty/work
Street address
24 Parvaneh, Yaman Street, Velenjak, P.O.Box:19395-4763 Tehran Tehran Iran
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
ramezani@endocrine.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences Shahid Beheshti
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
professor
Other areas of specialty/work
Street address
24 Parvaneh, Yaman Street, Velenjak, P.O.Box:19395-4763 Tehran Tehran Iran
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
ramezani@endocrine.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences Shahid Beheshti
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
professor
Other areas of specialty/work
Street address
24 Parvaneh, Yaman Street, Velenjak, P.O.Box:19395-4763 Tehran Tehran Iran
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)