Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Emergency Contraception
• Intervention / Treatment: Drug: Piroxicam 40 mg; Drug: Levonorgestrel 1.5mg

Detailed Description

Objective: To compare the percentage of pregnancies prevented by LNG co-administered with piroxicam or placebo for oral emergency contraception (EC) by a randomised controlled trial.

Hypothesis to be tested: LNG plus piroxicam has higher percentage of pregnancies prevented compared with LNG plus placebo for oral emergency contraception.

Design and subjects: This will be a prospective, randomised placebo-controlled clinical trial. Women attending the Family Planning Association of Hong Kong for oral EC within 72 hours of unprotected sexual intercourse will be recruited.

Study instruments: Prospective follow-up of subjects in the clinic for the primary and secondary outcomes.

Interventions: Eligible subjects will be randomised to receive one of the two treatment regimens, i.e. Group A: a single dose of LNG 1.5 mg and piroxicam 40 mg, or Group B: a single dose of LNG 1.5mg and placebo under direct supervision.

Main outcome measures: Percentage of pregnancies prevented (PPP) is the primary outcome measure. Secondary outcome measures include failure rate, rate of occurrence of side effects and pattern of the menstruation following EC.

Data analysis:The percentage of pregnancies prevented, failure rate and rate of occurrence of side effects will be compared between groups using Fisher-Exact test. Continuous variables regarding menstrual pattern between the two groups will be compared by Mann-Whitney U test.

Expected results: LNG plus piroxicam has a higher PPP compared to LNG plus placebo.

• Study Type: Interventional
• Enrollment (Actual): 860
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • The Family Planning Association of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Piroxicam; Piroxicam 40 mg (in 2 tablets) + levonorgestrel 1.5 mg single oral dose	Drug: Piroxicam 40 mg; Additional co-treatment; Drug: Levonorgestrel 1.5mg; Standard treatment
Placebo Comparator: Placebo; Placebo (2 tablets) + levonorgestrel 1.5 mg single oral dose	Drug: Levonorgestrel 1.5mg; Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Rate	number of participants who were pregnant / number of efficacy-evaluable participants	1 month

Collaborators and Investigators

• Sponsor: Dr. Hang Wun Raymond Li
• Collaborators: The Family Planning Association of Hong Kong
• Investigators: Principal Investigator: Hang Wun Raymond Li, MD, FRCOG, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Placebo; Levonorgestrel; Emergency contraception; Piroxicam; Randomised controlled control
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel; Piroxicam
• Other Study ID Numbers: UW18-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.
• IPD Sharing Time Frame: starting 6 months after publication of results
• IPD Sharing Access Criteria: To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No