Birth Control Pills and DNA Interaction

Phase 4

Recruiting

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serum ethinyl estradiol concentration

Serum etonogestrel concentration

Secondary study objectives

Modified Hoogland score

Positive and Negative Affect Scheduled

Serum albumin concentration

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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