Emergency Contraception Clinical Trial
Official title:
Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial
Verified date | November 2023 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomised controlled trial aimed at comparing the efficacy of levonorgestrel (LNG) co-administered with piroxicam or placebo for oral emergency contraception (EC). Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a pain-killer in inflammatory conditions. Efficacy will be measured as the percentage of pregnancies prevented.
Status | Completed |
Enrollment | 860 |
Est. completion date | October 5, 2022 |
Est. primary completion date | October 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - healthy women aged 18 years or above; - requesting emergency contraception within 72 h of a single act of unprotected intercourse in the current menstrual cycle; - having menstrual cycles between 24 and 42 days - willing to abstain from further acts of unprotected intercourse and; - available for follow-up over the next 6 weeks. Exclusion Criteria: - post-abortion or postpartum and period have not yet returned, - being on prescription drugs currently - having unprotected intercourse in this cycle more than 72 hours or more than once before attending the clinic, - being found pregnant at the time of presentation, - breastfeeding, - having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ, - uncertain about the date of the last menstrual period, - having used hormonal contraceptive (including EC pill) or NSAID in the current or past one cycle, - having history of asthma, urticarial or other allergic reactions to piroxicam, aspirin or other NSAIDs, - having history of ischaemic heart disease in the past one year - having history of pelvic ulcer disease and/or gastrointestinal bleeding |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Hong Kong | |
Hong Kong | The Family Planning Association of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Dr. Hang Wun Raymond Li | The Family Planning Association of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Pregnancies Prevented | (number of expected pregnancies - number of observed pregnancies) / number of expected pregnancies. The number of expected pregnancies is calculated based on the cycle day on which unprotected sexual intercourse occurred in each woman according to the model published by Trussel et al (Trussell J et al, Contraception 2003; 67:259-265). | 1 month | |
Secondary | Pregnancy Rate | number of participants who were pregnant / number of efficacy-evaluable participants | 1 month |
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