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.

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000722695

Enrollment

106

Registered

2014-07-08

Start date

2010-10-04

Completion date

2013-03-29

Last updated

2020-01-13

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 35 Years

Healthy volunteers

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.

Outcome results