Levonorgestrel + Meloxicam for Birth Control

(OVULATION Trial)

Overseen By William L. McPheat, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: InnovaGyn, Inc.

Must not be taking: Hormonal contraceptives, Liver enzyme inducers

Disqualifiers: Thyroid disorder, Heart disease, Thrombosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 19

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of two medications, levonorgestrel (a synthetic hormone) and meloxicam (an anti-inflammatory drug), can delay ovulation by seven days when taken just before ovulation. Researchers will compare this treatment's effects to a placebo to determine its effectiveness in delaying ovulation and to monitor any side effects, such as nausea or cramps. Women with regular menstrual cycles who are not using hormonal birth control might qualify for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you do not use hormonal contraception or a levonorgestrel-releasing intrauterine device. Additionally, you cannot use any medication that could interfere with the metabolism of hormonal contraceptives or non-steroidal anti-inflammatory drugs. If you are on any such medications, you may need to stop taking them to participate in the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that levonorgestrel, a common ingredient in emergency contraceptives like Plan B, is generally safe. Many have used it to prevent pregnancy after unprotected sex. Most users don’t experience serious side effects, though some report mild symptoms like nausea or headaches, which usually resolve quickly.

Meloxicam, a non-steroidal anti-inflammatory drug (NSAID), is typically safe when used as directed, though some might experience stomach discomfort or dizziness.

This study is in its early stages, so researchers are still learning about how these two drugs work together for birth control. However, since both drugs are already used safely for other purposes, there is a strong basis for their safety. Always consult a healthcare provider to understand more about what joining a trial like this could mean. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Levonorgestrel and Meloxicam for birth control because it offers a potentially new mechanism that current options don't. While standard birth control methods often rely on hormones to prevent ovulation, this treatment combines Levonorgestrel, a well-known hormone, with Meloxicam, an anti-inflammatory drug, to potentially influence ovulation timing more precisely. This unique pairing could offer more flexibility and effectiveness in preventing pregnancy, potentially reducing side effects associated with standard hormonal contraceptives. By targeting the ovulation process in a novel way, this combination may provide an alternative for those seeking different options in birth control.

What evidence suggests that this trial's treatments could be effective for delaying ovulation?

In this trial, participants will receive either an active intervention or a placebo. Research has shown that levonorgestrel, one of the active treatments, effectively serves as emergency contraception, preventing up to 89% of pregnancies if taken soon after unprotected sex. Additionally, meloxicam, another active treatment, may help delay egg release (ovulation) when used with levonorgestrel. This combination aims to delay ovulation for up to 7 days if taken just before ovulation is expected. Delaying ovulation is important because it provides more time to prevent fertilization. Early research suggests that using these two together could be a promising temporary birth control method by stopping ovulation for a short period. ^{3 6 7 8 9}

Who Is on the Research Team?

David F. Archer, MD

Principal Investigator

InnovaGyn, Inc.

William L. McPheat, PhD

Principal Investigator

InnovaGyn, Inc.

Are You a Good Fit for This Trial?

Healthy women aged 18-40 with regular menstrual cycles, intact reproductive organs, and not at risk of pregnancy can join this trial. They must live near the study site, have no chronic health issues or recent significant weight changes, and agree to avoid other clinical trials and certain medications.

Inclusion Criteria

Female in good general health with no chronic medical conditions that result in periodic exacerbations that require significant medical care

Intact uterus with both ovaries intact

Lives within the study catchment area or a reasonable distance from the study site

Exclusion Criteria

You have a history of heavy alcohol or marijuana use.

Women who smoke more than 15 cigarettes per day or use more than 1 milliliter of nicotine-containing liquid for electronic cigarettes per day.

You have a history of heart disease or stroke while pregnant or when using certain birth control methods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Control Cycle

Participants take placebo tablets when the ovarian follicle reaches 17 mm, with a second dose 48 hours later. Ovulation is monitored through urine samples and ultrasound.

4 weeks

9 visits (in-person)

Treatment Cycle

Participants take levonorgestrel plus meloxicam when the ovarian follicle reaches 17 mm, with a second dose 48 hours later. Ovulation is monitored through urine samples and ultrasound.

4 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and changes in blood pressure.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Levonorgestrel
• Meloxicam
• Placebo

Trial Overview The trial tests if a combination of levonorgestrel (a synthetic hormone) and meloxicam (an anti-inflammatory drug) taken orally can delay ovulation by seven days compared to a placebo. Women will take the medication when an ovarian follicle reaches a specific size detected via ultrasound.

How Is the Trial Designed?

Group I: Active intervention in Normal Ovulatory Women Active Control 2 Interventions

The second menstrual cycle for each participant is an active intervention arm. Levonorgestrel 1.5 mg plus meloxicam 15 mg will be taken when the ovarian follicle reaches 17 mm in largest diameter. The two medications will be repeated 48 hours later.

Group II: Placebo Comparator in Normal Ovulatory Women Placebo Group 1 Intervention

The two arm placebo comparator study will use each participant as her own control with a placebo arm in the first menstrual cycle consisting of two placebo tablets taken at the time of the ovarian follicle measuring 17 mm in diameter and a second dose of two tablets 48 hours later.

Levonorgestrel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Plan B One-Step for:

• Emergency contraception

Approved in European Union as Levonelle for:

• Emergency contraception

Approved in Canada as Postinor for:

• Emergency contraception

Approved in Japan as Levonorgestrel for:

• Emergency contraception

Who Is Running the Clinical Trial?

InnovaGyn, Inc.

Lead Sponsor

Trials

2

Recruited

40+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5102175/

Appreciation for analysis of how levonorgestrel works and ... The FDA has stated that Plan B is 89 percent effective in the prevention of expected clinical pregnancies (PDR 2005, s.v. “Plan B, Barr Laboratories, Inc.,” 779 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4216625/

Emergency contraception review: evidence-based ... Although the package insert indicates use for only 72 hours after unprotected sex, some research has shown levonorgestrel ECPs to be effective up to 4 days ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05695352

Oral Levonorgestrel Plus Meloxicam, IG-002 Delays ... Secondary outcomes are menstrual cramps, vaginal bleeding, nausea, and headache, and changes in blood pressure, pulse, and interval between menstrual periods in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590151624000042

Maximizing the effectiveness of 1.5 mg levonorgestrel for ... Results. Taking LNG-EC immediately after sex could potentially reduce the risk of unintended pregnancy by 91%. However, population-average maximum attainable ...

5. withpower.com withpower.com/trial/phase-2-pregnancy-prevention-5-2022-d1eb5

Levonorgestrel + Meloxicam for Birth Control This clinical trial determines if an oral medication taken within 2 days of anticipated ovulation will delay ovulation by 7 days.

6. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/plan-b-one-step-15-mg-levonorgestrel-information

Plan B One-Step (1.5 mg levonorgestrel) Information Plan B One-Step is an emergency contraceptive, a backup method to other birth control. It is in the form of one levonorgestrel pill (1.5 mg) ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf

Plan B One-Step (levonorgestrel) Tablet - accessdata.fda.gov Plan B® One-Step is an emergency contraceptive that helps prevent pregnancy after unprotected sex or when your birth control fails or is not used correctly.

8. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b7f49c5-8271-476d-9cbb-9f13e8a51f1d

Label: PLAN B ONE-STEP- levonorgestrel tablet - DailyMed Plan B One-Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex.

9. webmd.com webmd.com/drugs/2/drug-17833/levonorgestrel-oral/details

Levonorgestrel (Plan B One-Step, My Way, and others) Levonorgestrel is an over-the-counter (OTC) emergency contraceptive pill. It is used to reduce the chance of pregnancy after unprotected sex.