Home » Trials » SLCTR/2015/007
A Randomized Controlled Trial to compare the effectiveness of cyproterone acetate /ethinyl estradiol, desogestrel / ethinyl estradiol and metformin on improving hirsutism, hormonal and metabolic features of polycystic ovary syndrome.
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SLCTR Registration Number
SLCTR/2015/007
Date of Registration
The date of last modification
Oct 14, 2019
Trial Status
Scientific Title of Trial
A Randomized Controlled Trial to compare the effectiveness of cyproterone acetate /ethinyl estradiol, desogestrel / ethinyl estradiol and metformin on improving hirsutism, hormonal and metabolic features of polycystic ovary syndrome.
Public Title of Trial
Effect of two oral contraceptives and metformin on excessive hair growth and other metabolic and hormonal parameters of patients with polycystic ovary syndrome
Disease or Health Condition(s) Studied
polycystic ovary syndrome
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1163-9378
Any other number(s) assigned to the trial and issuing authority
2013/EC/52 (University of Peradeniya)
What is the research question being addressed?
What is the best combination or single treatment modality to treat patients with polycystic ovarian disease and hirsutism out of metformin, cyproterone acetate /ethinyl estradiol and desogestrel / ethinyl estradiol,?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
The study will be conducted at the department of Pharmacology, Faculty of medicine, University of Peradeniya, Sri Lanka. Consenting patients meeting inclusion/exclusion criteria will be randomized into four arms.
Arm 1 - Two mg of cyproterone acetate and 35 microg of ethinyl estradiol pill daily placebo pill equal to Metformin SR 500mg pill daily placebo pill equal to desogestrel 0.15mg/ ethinyl estradiol(20 microg) pill daily
Arm 2 - Desogestrel 0.15mg/ ethinyl estradiol(20 microg) daily placebo pill equal to metformin SR 500mg pill daily placebo pill equal to 2 mg of cyproterone acetate and 35 microg of ethinyl estradiol pill daily
Arm 3 - Metformin (SR) 500mg daily 2 mg of cyproterone acetate and 35 microg of ethinyl estradiol daily placebo pill equal to desogestrel 0.15mg/ ethinyl estradiol(20 microg) pill daily
Arm 4 - Metformin(SR) 500mg daily desogestrel 0.15mg/ ethinyl estradiol(20 microg) daily placebo pill equal to 2 mg of cyproterone acetate and 35 microg of ethinyl estradiol pill daily
These drugs will be given for duration of one year for all four arms.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Hirsuitism as measured by 1.1. Objective hair measures Patients will be instructed not to remove hair by any means at least 5 days before the measurements. They will be asked to keep a note on date of hair removal before performing the hair removal. On the day of the measurements, the date and time of the last shaving will be recorded to establish the shaving interval (days). The primary investigator, who will be blinded, will obtain all measures. 1.2. Hair growth rate At least three photographs of the cheek/chin areas will be taken at each study time, using a digital camera. 1.3. Plucking. After photography, five cheek or chin hairs will be plucked with regular facial tweezers. The hair samples will then be fixed to a glass slide using Histomount mounting medium in xylene and will be protected with a cover slip. Using an overhead projector, the hair will be projected onto a screen, where they will be traced on paper. The total length of the hair will be measured using a digital plan measure. To calibrate the overhead projection, a stage micrometer will be projected onto the screen and traced. Each of the projected hair lengths will be then converted to actual millimeters. The results of the five hairs measured at each study time will be averaged to produce one mean length. This value will be divided by the shaving interval (in days) to get the hair growth rate (mm/day) 1.4. Hair diameter The diameter of each of the plucked hair will be obtained using an Olympus B× 50 magnification and image will be projected onto a monitor screen. Using a ruler in millimeters, the outer diameter of the hair at mid shaft will be obtained and will be converted to actual millimeters by comparing it to the projected screen micrometer. The diameters of the five hairs obtained at each study time will be averaged to take the mean. These measures will be done at the department of Pathology, Faculty of Medicine, University of Peradeniya, Sri Lanka. 1.5. Hair density Using the photographs of cheek hair, a circular area measuring 2 cm in diameter will be marked, the number of hairs arising within the circle will be counted, and the hair density will be calculated. Three photographs at each study time will be taken and average density will be taken. 1.6. Hirsutism Score Hirsutism will be assessed clinically, using Modified Ferriman-Gallwey classification |
[ At baseline, end of 6 months and end of 12 months. ] |
Secondary outcome(s)
|
1.
Waist circumference 2. Waist to height ratio 3. Body mass index 4. menstrual cyclicity – number of cycles per year and menstrual flow 5. Blood pressure 6. Side effect profile of drugs 7. Health related Quality of life – Polycystic Ovary Syndrome Questionnaire ( Singhalese translation ) 8. Oral glucose tolerance test (OGTT)- beginning and at the end of the study 9. Measurement of fasting blood glucose , insulin levels and Homeostasis Model Assessment (HOMA) index 10. Plasma adipokines ( leptin and adiponectin) 11. Lipid profile 12. Total testosterone ( early morning , between 4th and 10th day of menstrual cycle or women with amenorrhea) 13. Sex hormone binding globulin(SHBG) 14. Free androgen index [total testosterone (nM)/SHBG (nM) × 100] 15. Endometrial thickness 16. Liver enzymes – SGOT/ SGPT 17. Ultra sound scan of liver to detect fatty liver |
[ Outcomes 1- 7 and 16 at the beginning of the study, at the end of 3rd month, at the end of 6th month, at the end of 9th month, at the end of 12th month Outcomes 8-15 and 17 at the beginning and at the end of 12th month ] |
Target number/sample size
100
Countries of recruitment
Sri Lanka
Anticipated start date
2015-04-01
Anticipated end date
2017-04-30
Date of first enrollment
2015-04-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
University Grants Commission, Sri Lanka. UGC/VC/DRIC/PG/2013/PDN/03
Regulatory approvals
Status
Approved
Date of Approval
2013-11-13
Approval number
2013/EC/52
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Sanjeewani Fonseka
lecturer
Department of Pharmacology, Faculty of Medicine, University of Peradeniya, Sri Lanka
+94 718074979
sanjeewani.fonseka@yahoo.com
Primary study sponsor/organization
University Grants Commission, Sri Lanka
No 20, Ward Place
Colombo 7, Sri Lanka
+94 11 2 695301
+94 11 2688045
chairman@ugc.ac.lk
www.ugc.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
