Phase II Study of Ovulation in Obese Women

PHASE2RecruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

December 10, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Pregnancy Prevention
Interventions
DRUG

Levonorgestrel 0.15 milligram

The study design is an open label randomized single blind clinical trial in which each participant will receive placebo two tablets 48 hours apart in their first menstrual cycle and then levonorgestrel plus meloxicam 48 hours apart in their subsequent menstrual cycle. We will compare the interval from taking the first dose of medication to the development of a functioning corpus luteum based on the shift in the ratio of urinary estrone-3-glucuronide(EC) / pregnanediol-3-glucuronide (PDG).

DRUG

Meloxicam 15 milligram

The study design is an open label randomized single blind clinical trial in which each participant will receive placebo two tablets 48 hours apart in their first menstrual cycle and then levonorgestrel plus meloxicam 48 hours apart in their subsequent menstrual cycle. We will compare the interval from taking the first dose of medication to the development of a functioning corpus luteum based on the shift in the ratio of urinary estrone-3-glucuronide(EC) / pregnanediol-3-glucuronide (PDG).

OTHER

calcium carbonate 750 milligram

The study design is an open label randomized single blind clinical trial in which each participant will receive placebo two tablets 48 hours apart in their first menstrual cycle and then levonorgestrel plus meloxicam 48 hours apart in their subsequent menstrual cycle. We will compare the interval from taking the first dose of medication to the development of a functioning corpus luteum based on the shift in the ratio of urinary estrone-3-glucuronide(EC) / pregnanediol-3-glucuronide (PDG).

Trial Locations (1)

27713

RECRUITING

Carolina Women's Research and Wellness Center, Raleigh

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

InnovaGyn, Inc.

OTHER