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Hormone Therapy

Active intervention in Normal Ovulatory Women 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.
Awards & highlights

OVULATION Trial 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.Check my eligibility
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.See study design
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.

OVULATION Trial 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. 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 to ovulation in normal women following placebo is 3 days compared to 7 days following levonorgestrel plus meloxicam
Secondary outcome measures
Safety using Blood pressure
Other outcome measures
Change in menstrual bleeding interval or unscheduled bleeding compared between interventions
Compare adverse events between treatments

OVULATION 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
1,956 Previous Clinical Trials
2,672,199 Total Patients Enrolled
David F. Archer, MDPrincipal InvestigatorInnovaGyn, Inc.

Media Library

Levonorgestrel (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05695352 — Phase 2
Birth Control Research Study Groups: Placebo Comparator in Normal Ovulatory Women, Active intervention in Normal Ovulatory Women
Birth Control Clinical Trial 2023: Levonorgestrel Highlights & Side Effects. Trial Name: NCT05695352 — Phase 2
Levonorgestrel (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695352 — Phase 2

Frequently Asked Questions

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

Are the elderly being considered for participation in this clinical experiment?

"As set out in the study's criteria for participation, participants must be between 18 and 40 years old."

Answered by AI

Has the FDA approved Active intervention in Normal Ovulatory Women yet?

"According to our team's assessment, the safety rating of Active intervention in Normal Ovulatory Women is 2. This refers to a Phase 2 trial, which has validating data on its security but not yet enough evidence for efficiency."

Answered by AI

Is enrollment for this experiment currently open?

"Data available on clinicaltrials.gov reveals that this medical experiment is currently accepting participants. Initially posted on June 28th 2022, the trial has been amended as recently as January 12th 2023."

Answered by AI

How frequently are individuals enrolling in this research project?

"That is correct. According to clinicaltrials.gov, this trial began on June 28th 2022 and has been actively recruiting since then. It requires 21 people across one site in order to complete the study's enrollment goals."

Answered by AI

Am I eligible to partake in this research experiment?

"Only those within the age range of 18 and 40, who are taking appropriate contraceptive measures, can be considered for this study. A maximum of 21 patients will eventually be enrolled in the trial."

Answered by AI
~3 spots leftby Jul 2024