Phase II Study of Ovulation in Obese Women

Summary

The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are:

1. Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo.
2. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments \[placebo versus levonorgestrel plus meloxicam\].

Participants will:

* undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam,
* maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding,
* collect daily first morning voided urine from menstrual day 9 to 24,
* undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14.
* allow a blood sample to be drawn on days with ultrasound scans.
* Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later.

Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs

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).

Sponsors & Collaborators

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

  collaborator NIH

• InnovaGyn, Inc.

  lead OTHER

Principal Investigators

• Andrea Lukes, MD · Carolina Woman's Research and Wellness Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-10

Primary Completion

2025-11-30

Completion

2025-11-30

FDA Drug

Yes

Countries

• United States

Study Locations