Actively Recruiting
Phase II Study of Ovulation in Obese Women
Led by InnovaGyn, Inc. · Updated on 2025-08-22
22
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
I
InnovaGyn, Inc.
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Phase II Study of Ovulation in Obese Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female in good general health without chronic medical conditions causing frequent exacerbations
- Age between 18 to 40 years inclusive at enrollment
- BMI of 30 kg/m8 or higher with no recent rapid weight changes
- Intact uterus and both ovaries present
- Recent Papanicolaou test per guidelines; test done at screening if none available and participant is 21 or older
- Regular menstrual cycles of 24 to 32 days; with specific requirements if postpartum or after pregnancy loss
- Negative urine pregnancy test on menstrual cycle day 9 before treatment
- Not at risk of pregnancy during study by being abstinent, permanently sterilized, or using non-hormonal contraception consistently
- Willing and able to comply with study protocol
- Willing to collect and store daily first morning urine samples
- Lives within reasonable distance of study site
- Understands and signs informed consent
- Agrees not to join other clinical trials during this study
- Screening serum progesterone level above 3 ng/ml
You will not qualify if you...
- Known allergy or contraindications to progestins
- Abnormal ultrasound or lab results deemed clinically significant during screening
- Known or suspected alcohol or marijuana abuse
- Undiagnosed abnormal genital bleeding or vaginal abnormalities
- Women with frequent genital herpes outbreaks (infrequent allowed with antiviral use)
- Uncontrolled thyroid disorder
- Current use of hormonal contraception or levonorgestrel intrauterine device
- Recent use of long-acting injectable hormonal contraception without subsequent spontaneous menstruation
- Breastfeeding without return of spontaneous menstrual bleeding
- Planned major surgery during study
- Plans to become pregnant during study
- Smoking more than 15 cigarettes daily or heavy use of nicotine vaping
- History of heart disease, stroke with pregnancy or hormonal contraception use
- History of blood clots or clotting disorders
- Personal or family history of thrombophilia
- History of retinal vascular problems or vision loss
- Known or suspected hormone-sensitive cancers
- Other cancers unless in remission over 5 years
- Severe depression unless stable on medication
- History of headaches with neurological symptoms
- Need for hormones or anticoagulants during study
- History of liver or gallbladder problems related to hormones
- Significant liver disease or tumors
- High blood pressure above specified limits unless controlled
- Abnormal serum chemistry considered significant
- Participation in other clinical trials recently or planned
- Use of liver enzyme-inducing medications
- Known HIV infection
- History of gastrointestinal ulcers or bleeding
- Use of excluded medications
- Investigator concerns about compliance or study reliability
- Allergy to levonorgestrel or NSAIDs
- Use of medications interfering with contraceptive or NSAID metabolism
- Site staff or close relations involved in study duties
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Carolina Women's Research and Wellness Center
Raleigh, North Carolina, United States, 27713
Actively Recruiting
Research Team
D
David F. Archer, MD
CONTACT
W
William McPheat, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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