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.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000722695
• Date of registration: 08/07/2014
• Prospective Registration: No
• Primary sponsor: Recep Yildizhan
• 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
• Date of first enrolment: 04/10/2010
• Target sample size: 106
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000722695.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;

Countries of recruitment

Turkey

Contacts

• Name: Dr Recep Yildizhan, M.D., Associate Professor

• Name: Dr Recep Yildizhan, M.D., Associate Professor

Key inclusion & exclusion criteria

Inclusion criteria: Polycystic ovary syndrome
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.

Age minimum: 18 Years
Age maximum: 35 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Other metabolic disorders

Reproductive Health and Childbirth - Contraception

Polycystic ovary syndrome;Contraception;
Polycystic ovary syndrome
Contraception

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Intervention(s)

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.

Primary Outcome(s)

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.
[On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months.]

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.[On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months.]

Secondary Outcome(s)

Body mass index
The body mass index (BMI) was calculated as weight (kg) / height square (m2).[On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months]

waist/hip ratio (WHR)
Waist and hip circumferences were measured and waist/hip ratio (WHR) was calculated.[On day 3 of the follicular phase of the menstrual cycle at baseline, 6 months, 12 months and 24 months]

Secondary ID(s)

Nil