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Hormone Therapy
Levonorgestrel + Meloxicam for Birth Control (OVULATION Trial)
Phase 2
Recruiting
Led By David F. Archer, 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 events are measured from day 1 to end of cycle in placebo compared to intervention cycle with each cycle 28 ± 2.0 days. measurement are made in up to two menstrual cycles.
Summary
This trial determines if medication taken 2 days before ovulation can delay ovulation by 7 days, and the side effects of the treatment vs control.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include menstrual cramps, vaginal bleeding, nausea, headache, changes in blood pressure or pulse rate. The impact on the interval between menstrual periods is also being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ events are measured from day 1 to end of cycle in placebo compared to intervention cycle with each cycle 28 ± 2.0 days. measurement are made in up to two menstrual cycles.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~events are measured from day 1 to end of cycle in placebo compared to intervention cycle with each cycle 28 ± 2.0 days. measurement are made in up to two menstrual cycles.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Interval to ovulation in normal women following placebo is 3 days compared to 7 days following levonorgestrel plus meloxicam
Secondary study objectives
Safety using Blood pressure
Other study objectives
Change in menstrual bleeding interval or unscheduled bleeding compared between interventions
Compare adverse events between treatments
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active intervention in Normal Ovulatory WomenActive Control2 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 WomenPlacebo Group1 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.
Find a Location
Who is running the clinical trial?
InnovaGyn, Inc.Lead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,686 Total Patients Enrolled
David F. Archer, MDPrincipal InvestigatorInnovaGyn, Inc.
William L. McPheat, PhDStudy DirectorInnovaGyn, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You are allergic to levonorgestrel or non-steroidal anti-inflammatory drugs (NSAIDs).You have an unknown vaginal discharge or any unusual sores or problems in the genital area. If you have a history of genital herpes, you can still participate if you don't have frequent outbreaks and are taking antiviral medication.You have a known allergy or reasons why you shouldn't take progestins.Your thyroid disorder is not under control.You have had other types of cancer, except for non-serious skin cancers, and you have been cancer-free for more than 5 years.You have unexplained or unusual bleeding from your genitals.You or someone in your family has a history of blood clotting issues.You have a history of headaches accompanied by specific problems with your brain or nerves.You have had stomach or intestinal ulcers or bleeding in the past.You have other types of liver tumors or currently have a liver disease.You have experienced yellowing of the skin during pregnancy or after using certain steroid hormones.You have a history of eye problems that affect the blood vessels or have experienced partial or complete vision loss.You have been diagnosed with or are suspected to have cancer in the breast, uterus, or other areas that are sensitive to progestin.You currently need to take hormones or blood thinning medication.
Research Study Groups:
This trial has the following groups:- Group 1: Active intervention in Normal Ovulatory Women
- Group 2: Placebo Comparator in Normal Ovulatory Women
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.