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

Phase 4

Recruiting

• Conditions: Contraception; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12609000391279
• Lead Sponsor: Family Planning NSW

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

Can be new users, restarters or switchers
No contraindications to combined hormonal contraceptive use
Willing to give informed consent to randomisation
Willing to be contacted monthly by research assistant and to maintain a menstrual chart
Willing to have a blood samples taken at inclusion and completion of study for biochemical and haematological testing.
Willing to keep account of sanitary protection used and cost over duration of study.

Exclusion Criteria

Currently pregnant or trying to get pregnant.
Sterilisation.
Contraindications to combined hormonal contraceptive use
Smokers aged = 35 years and over are excluded
Depot medroxyprogestogen acetateuse within last six months
Undiagnosed intermenstrual bleeding
Problems with cycle control whilst taking combined oral contraceptives leading to discontinuation
Unwilling to stop taking non-steroidal anti-inflammatory drugs
Taking any concomitant medications which cause enzyme induction and could effect steroidal blood levels

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of bleeding/spotting days over a 12 month treatment period from information recorded on a daily bleeding diary and verified by telephone and face to face interviews[The total number of bleeding/spotting days will be calculated for the 12 month study period but divided into 4 X 90 day reference periods as recommended by the World Health Organisation.]

Secondary Outcome Measures

Name	Time	Method
Comparison of haematological and biochemical parameters prior to starting the contraceptive method and at termination of the method.[Prior to inclusion in the study and at the termination visit.];To determine whether 4 days cessation of treatment is sufficient to stop an episode of breakthrough bleeding (BTB) determined from a daily bleeding diary and verified by telephone and face to face interviews.[Over the 12 months study period this will be assessed for each 90 day reference period from the bleeding diaries and verified by telephone and face to face interviews]