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Trial registered on ANZCTR


Registration number
ACTRN12614000722695
Ethics application status
Approved
Date submitted
30/06/2014
Date registered
8/07/2014
Date last updated
8/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the metabolic and hormonal effects of two oral contraceptives in women with polycystic ovary syndrome (PCOS) for a period of two years follow-up.
Scientific title
Comparison of the effects of two oral contraceptive pills (OCPs) containing either chlormadinone acetate or drospirenone as the progestogen,on metabolic and hormonal parameters in women with polycystic ovary syndrome (PCOS) for a period of two years follow-up
Secondary ID [1] 284880 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic ovary syndrome 292316 0
Contraception 292317 0
Condition category
Condition code
Reproductive Health and Childbirth 292655 292655 0 0
Contraception
Reproductive Health and Childbirth 292710 292710 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 292711 292711 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
120 subjects were randomized into two groups. Group A received ethinyl estradiol 0.03 mg + Drospirenone 3mg (EE+DRSP; n=60) and Group B received ethinyl estradiol 0.03 mg+Chlormadinone acetate 2 mg (EE+CMA; n=60). In Group A, one patient at 6 months, two patients at 12 months discontinued the treatment. At 24 months one patient was lost to follow up and 56 subjects completed the study. In Group B, two patients at 6 months, two patients at 12 months and three patients at 24 months discontinued the treatment. One patient at 12 months, two patients at 24 months were lost to follow up and 50 subjects completed the study. Thus analyses were performed for 56 subjects in group A and 50 subjects in Group B.All subjects were advised to take the oral tablets once daily and with appropriate instructions cyclically ( 21 pill intake days followed by 7 pill free days) for 24 months. Oral tablet return was checked every 3 months to monitor adherence. Clinical, hormonal and biochemical parameters were compared at baseline, 6 months, 12 months and 24 months.
Intervention code [1] 289691 0
Treatment: Drugs
Comparator / control treatment
Group A received ethinyl estradiol 0.03 mg + Drospirenone 3mg and Group B received ethinyl estradiol 0.03 mg+Chlormadinone acetate 2 mg. The effects of two oral contraceptive pills were compared. Group A is considered to be the comparator treatment
Control group
Active

Outcomes
Primary outcome [1] 292502 0
free androgen index (FAI)
Free androjen index (FAI) was calculated by the formula,
FAI = (Total testesterone nmol/L) / sex hormone-binding globulin nmol/L) x 100.
total testesterone and sex hormone-binding globulin levels were determined by serum assay.
Timepoint [1] 292502 0
On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months.
Primary outcome [2] 292551 0
Insulin resistance, defined by the homeostasis model assessment insulin resistance index (HOMA-IR), which was calculated using the following equation: HOMA-IR = fasting insulin (microU/L) x fasting glucose (mmol/L)/22.5
fasting insulin and glucose levels were determined by serum assay.
Timepoint [2] 292551 0
On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months.
Secondary outcome [1] 309112 0
Body mass index
The body mass index (BMI) was calculated as weight (kg) / height square (m2).
Timepoint [1] 309112 0
On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months
Secondary outcome [2] 309206 0
waist/hip ratio (WHR)
Waist and hip circumferences were measured and waist/hip ratio (WHR) was calculated.
Timepoint [2] 309206 0
On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months

Eligibility
Key inclusion criteria
Polycystic ovary syndrome
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The subjects took no medications (oral contraceptives, glucocorticoids, antiandrogens, insulin sensitizers, ovulation induction agents, or antiobesity drugs) that could affect the biochemical profile and metabolic variables for at least 6 months before entering the study. The exclusion criteria included Cushing’s syndrome, congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, virilizing tumors, glucose intolerence or diabetes mellitus, hepatic dysfunction, renal dysfunction, hypertension and any contraindications for the use of combined oral contraceptives.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6178 0
Turkey
State/province [1] 6178 0

Funding & Sponsors
Funding source category [1] 289504 0
Self funded/Unfunded
Name [1] 289504 0
Address [1] 289504 0
Country [1] 289504 0
Primary sponsor type
Individual
Name
Recep Yildizhan
Address
Department of Obstetrics and Gynecology, Yuzuncu Yil University, Kazim Karabekir Cad, 65080,Van, Turkey
Country
Turkey
Secondary sponsor category [1] 288185 0
None
Name [1] 288185 0
Address [1] 288185 0
Country [1] 288185 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Drospirenone containing combined oral contraceptive (COC) is found to have more favorable effects on lipid profiles, high sensitive C reactive protein levels, insulin resistance and hyperandrogenism when compared with the chlormadione acetate containing COC and appears to be more beneficial for the long term cardiovascular and metabolic aspects of PCOS.
Trial website
Trial related presentations / publications
The results have not been presented or published.
Public notes

Contacts
Principal investigator
Name 49526 0
Dr Recep Yildizhan, M.D., Associate Professor
Address 49526 0
Department of Obstetrics and Gynecology, Yuzuncu Yil University, Kazim Karabekir Cad, 65080,Van, Turkey
Country 49526 0
Turkey
Phone 49526 0
+905323267404
Fax 49526 0
Email 49526 0
recepyildizhan@yahoo.com
Contact person for public queries
Name 49527 0
Dr Recep Yildizhan, M.D., Associate Professor
Address 49527 0
Department of Obstetrics and Gynecology, Yuzuncu Yil University, Kazim Karabekir Cad, 65080,Van, Turkey
Country 49527 0
Turkey
Phone 49527 0
+905323267404
Fax 49527 0
Email 49527 0
recepyildizhan@yahoo.com
Contact person for scientific queries
Name 49528 0
Dr Recep Yildizhan, M.D., Associate Professor
Address 49528 0
Department of Obstetrics and Gynecology, Yuzuncu Yil University, Kazim Karabekir Cad, 65080,Van, Turkey
Country 49528 0
Turkey
Phone 49528 0
+905323267404
Fax 49528 0
Email 49528 0
recepyildizhan@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary