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Hormone Therapy

Combined oral contraceptive pill users for Birth Control

Phase 4

Waitlist Available

Led By Aaron M Lazorwitz, MD, PhD

Research Sponsored by Yale University

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 measured on cycle 1, day 22 (all participants), repeated measure in cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)

Awards & highlights

Study Summary

This trial aims to understand how differences in our DNA can affect how our bodies process hormones in birth control pills, potentially influencing their effectiveness in preventing pregnancy and causing different side effects in individuals. Participants will take

Who is the study for?

This trial is for individuals using a specific birth control pill (desogestrel/ethinyl estradiol). It's focused on how genetic differences affect the body's processing of these hormones and their effectiveness in preventing pregnancy. Participants will have blood tests, answer questionnaires about side effects, and may opt for an ultrasound to check ovarian follicles.Check my eligibility

What is being tested?

The study is testing how the CYP3A7*1C gene variant affects metabolism of hormones in oral contraceptives and if it leads to more cases of breakthrough ovulation. It also seeks new genetic factors that influence hormone levels among users of these pills.See study design

What are the potential side effects?

Possible side effects from taking the combined oral contraceptive pill include nausea, headaches, mood changes, weight gain, menstrual irregularities, and other hormonal-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured on cycle 1, day 22 (all participants), repeated measure in cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured on cycle 1, day 22 (all participants), repeated measure in cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured on cycle 1, day 22 (all participants), repeated measure in cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Serum ethinyl estradiol concentration

Serum etonogestrel concentration

Secondary outcome measures

Modified Hoogland score

Positive and Negative Affect Scheduled

Serum albumin concentration

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combined oral contraceptive pill usersExperimental Treatment1 Intervention

Administered a combined oral contraceptive pill containing desogestrel and ethinyl estradiol (Desogen, 0.15mg desogestrel and 0.03mg ethinyl estradiol per active pill) for at least one cycle (21 days) and up to 13 total cycles (one year)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,737,861 Total Patients Enrolled

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

1,965 Previous Clinical Trials

2,672,097 Total Patients Enrolled

Aaron M Lazorwitz, MD, PhDPrincipal InvestigatorYale School of Medicine

Frequently Asked Questions

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

Are individuals above the age of 50 eligible for enrollment in this research study?

"Only individuals aged between 18 and 45 years are eligible for enrollment in this study. There are a total of 20 trials catering to those under 18 and 17 designed for participants older than 65."

Answered by AI

Are participants currently being recruited for this study?

"The current information on clinicaltrials.gov indicates that recruitment for this specific trial is not ongoing. This trial was first listed on May 1, 2024, and the last update occurred on March 20, 2024. Despite this particular study no longer enrolling participants, there are currently 56 other trials actively seeking eligible candidates."

Answered by AI

Are individuals who take a combination oral contraceptive pill considered to be approved by the FDA?

"Given that this clinical investigation is designated as a Phase 4 trial, our experts at Power have rated the safety level of users of combined oral contraceptive pills as 3 on our scale. This assessment indicates that the treatment has received official approval for use."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"The objective of this investigation, to be evaluated on Cycle 1, Day 22 using a trough concentration (each cycle lasts for 28 days), is the assessment of serum etonogestrel levels. Additionally, secondary endpoints comprise measuring serum progesterone concentrations as an indicator of endogenous progesterone activity, monitoring sex hormone binding globulin levels as a marker of estrogen effects, and evaluating serum estradiol concentrations to assess natural estrogen dynamics."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Contraceptive Pill (OCP) Pharmacogenomics

2024. "Oral Contraceptive Pill (OCP) Pharmacogenomics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06334315.