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Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

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ClinicalTrials.gov Identifier: NCT03614494
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
The Family Planning Association of Hong Kong
Information provided by (Responsible Party):
Dr. Hang Wun Raymond Li, The University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Emergency Contraception Drug: Piroxicam 40 mg Drug: Levonorgestrel 1.5mg Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of pregnancies prevented [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 1 month ]
  2. Significant adverse events [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females are eligible
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614494


Contacts
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Contact: Hang Wun Raymond Li, MBBS, FRCOG +852 22554517 raymondli@hku.hk
Contact: Ernest Hung Yu Ng, MD, FRCOG +852 22554700 nghye@hku.hk

Locations
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Hong Kong
Queen Mary Hospital Active, not recruiting
Hong Kong, Hong Kong
The Family Planning Association of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Sue Lo, MD, FRCOG    29197726    stlo@famplan.org.hk   
Sponsors and Collaborators
Dr. Hang Wun Raymond Li
The Family Planning Association of Hong Kong
More Information
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Responsible Party: Dr. Hang Wun Raymond Li, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03614494    
Other Study ID Numbers: UW18-003
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Hang Wun Raymond Li, The University of Hong Kong:
Piroxicam
Levonorgestrel
Placebo
Randomised controlled control
Emergency contraception
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Piroxicam
Levonorgestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
 Contraceptives, Oral
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action