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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000391279

Acronym

N/A

Enrollment

140

Registered

2009-06-01

Start date

2009-03-07

Completion date

Unknown

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

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Outcome results