Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

NCT03614494 | Completed Phase 2 Results

• 1 other identifier: UW18-003
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Emergency Contraception

Keywords

Piroxicam; Levonorgestrel; Placebo; Randomised controlled control; Emergency contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pregnancy Rate

  1 month

Study Arms (2)

Piroxicam

ACTIVE COMPARATOR

Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose

Drug: Piroxicam 40 mg; Drug: Levonorgestrel 1.5mg

Placebo

PLACEBO COMPARATOR

Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose

Drug: Levonorgestrel 1.5mg

Interventions

Piroxicam 40 mg DRUG

Additional co-treatment

Piroxicam

Levonorgestrel 1.5mg DRUG

Standard treatment

Piroxicam; Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females are eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Hang Wun Raymond Li: lead
• The Family Planning Association of Hong Kong: collaborator

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

The Family Planning Association of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Li RHW, Lo SST, Gemzell-Danielsson K, Fong CHY, Ho PC, Ng EHY. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial. Lancet. 2023 Sep 9;402(10405):851-858. doi: 10.1016/S0140-6736(23)01240-0. Epub 2023 Aug 16.

  PMID: 37597523 DERIVED

MeSH Terms

Interventions

Piroxicam; Levonorgestrel

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr Raymond Li
• Organization: The University of Hong Kong

raymondli@hku.hk

+852 22554517

Study Officials

• Hang Wun Raymond Li, MD, FRCOG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 3, 2018
• Study Start: August 20, 2018
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication of results
• Access Criteria: To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.

Locations

HK (2)