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Hormone Therapy

Levonorgestrel + Meloxicam for Birth Control

Phase 2
Recruiting
Led By Andrea Lukes, MD
Research Sponsored by InnovaGyn, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the blood pressure is monitored at screening and from menstrual day 9 to 24 in each of two treatment cycles.

Summary

This trial aims to see if a combination of two medications, levonorgestrel and meloxicam, can delay ovulation in obese women with normal menstrual cycles compared to a placebo. Participants will

Who is the study for?
This trial is for obese women with regular menstrual cycles. Participants will undergo two treatment cycles, one with a placebo and the other with levonorgestrel plus meloxicam. They must keep daily logs, provide urine samples, have ultrasound scans, and allow blood draws.
What is being tested?
Researchers are testing if ovulation can be delayed by at least 7 days using levonorgestrel combined with meloxicam versus a placebo in obese women. The study also looks for differences in unscheduled bleeding or side effects between treatments.
What are the potential side effects?
Possible side effects include changes in menstrual patterns, unscheduled vaginal bleeding, potential adverse reactions to medications like headaches or nausea, and any changes observed during daily health logs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pulse rate is measured at all visits throughout the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and pulse rate is measured at all visits throughout the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Interval from first dose to evidence of ovulation.
Secondary study objectives
Change in Pulse
Change in blood pressure
Other study objectives
Unscheduled endometrial bleeding and changes in interval, amount and duration of menstrual bleeding.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Levonorgestrel plus meloxicamActive Control2 Interventions
The active comparator is levonorgestrel 1.5 milligram (mg) and meloxicam 15 milligram (mg) taken together orally and repeated 48 hours later.
Group II: PlaceboPlacebo Group1 Intervention
The placebo is calcium carbonate 750 milligram (mg) known as TUMS. Each participant will take one tablet orally and repeat 48 hours later.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,864 Total Patients Enrolled
InnovaGyn, Inc.Lead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Andrea Lukes, MDPrincipal InvestigatorCarolina Woman's Research and Wellness Center
1 Previous Clinical Trials
40 Total Patients Enrolled
~0 spots leftby Dec 2024
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