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Hormone Therapy

Levonorgestrel plus 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 daily diary cards will be kept by each participant beginning menstrual day 9 of first cycle. diary cards will be returned at the exit visit within two weeks of the final (second) menstrual period.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ the blood pressure is monitored at screening and from menstrual day 9 to 24 in each of two treatment cycles.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the blood pressure is monitored at screening and from menstrual day 9 to 24 in each of two treatment cycles. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interval from first dose to evidence of ovulation.

Secondary outcome measures

Change in Pulse

Change in blood pressure

Other outcome measures

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

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

1,965 Previous Clinical Trials

2,672,775 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than twenty years of age eligible to participate in this clinical trial?

"The trial is seeking individuals above 18 years and under 40 years of age to participate."

Answered by AI

What is the total number of participants being recruited for this clinical investigation?

"Indeed, the details on clinicaltrials.gov affirm that this research study is actively seeking suitable candidates. The trial was initially shared on December 10th, 2023 and last modified on March 8th, 2024. There is a need to enroll 22 participants at one designated site."

Answered by AI

Which specific criteria must individuals meet in order to be eligible for participation in this medical study?

"Candidates seeking entry into this research study must meet the criteria of utilizing contraception methods and falling within the age bracket of 18 to 40 years old. The trial aims to enroll approximately 22 eligible participants."

Answered by AI

Are there any ongoing efforts to enroll patients in this clinical trial?

"As indicated on clinicaltrials.gov, patient recruitment for this trial is currently ongoing. The trial was initially listed on 12th October 2023 and last revised on 8th March 2024."

Answered by AI

Has the combination of Levonorgestrel and meloxicam received approval from the FDA?

"The safety assessment of the combination Levonorgestrel and meloxicam has been rated as 2 by our team at Power, based on it being a Phase 2 trial. This rating suggests that there is existing safety data available but no evidence supporting its efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Ovulation in Obese Women

2023. "Phase II Study of Ovulation in Obese Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06306131.

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