RecruitingPhase 4ACTRN12609000391279

Comparative 12 month study of menstrually-signalled use of a combined contraceptive pill versus a combined contraceptive vaginal ring

Comparative 12 month study of menstrually-signalled use of an ethinyl oestradiol and levonorgestrel low-dose pill and a low-dose contraceptive vaginal ring containing ethinyl oestradiol and etonogestrel to assess the number of bleeding spotting days


Sponsor

Family Planning NSW

Enrollment

140 participants

Start Date

Mar 7, 2009

Study Type

Interventional

Conditions

Summary

Women requiring hormonal contraception who have consented to enter the study will complete a menstrual attitude questionnaire and undergo physical and gynaecological examination and routine haematological and biochemical tests before being randomly assigned to continuous ring or pill use. Women will maintain menstrual diaries for the 12 month study duration. If a bleeding/spotting episode excedes 4 days they will stop their method for 4 days and restart on the fifth day. Women will be contacted monthly to ensure compliance and will be seen at 2 months, 6 months and 12 months from randomisation for follow up At each visit the women will complete an acceptability questionnaire and a menstrual attitudes questionnaire at the final visit.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of hormone-based contraception used in a way that reduces or eliminates monthly periods: a combined contraceptive pill and a vaginal ring. Both methods are used continuously, with a short break only when bleeding or spotting lasts more than 4 days. The study runs for 12 months and looks at how well each method controls bleeding, how acceptable it is, and what women think about having fewer periods. You may be eligible if: - You are a woman between 18 and 45 years old - You need contraception and have no medical reason to avoid combined hormonal contraceptives - You are willing to be contacted monthly and keep a menstrual diary - You are willing to have blood tests at the start and end of the study You may NOT be eligible if: - You are currently pregnant or trying to become pregnant - You have had a sterilisation procedure - You are a smoker aged 35 or older - You have received depot contraceptive injections in the last 6 months - You have unexplained bleeding between periods - You are taking certain medications that may interfere with contraceptive hormones Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Use of a low dose oral contraceptive pill containing ethinyl oestradiol 20mcg and levonorgestrel 100mcg once daily for a total of 12 months

Use of a low dose oral contraceptive pill containing ethinyl oestradiol 20mcg and levonorgestrel 100mcg once daily for a total of 12 months


Locations(1)

Australia

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ACTRN12609000391279


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