Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how our bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. We also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are: - Do individuals with the CYP3A7*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill? - Do individuals with the CYP3A7*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill? - What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users? Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures: - Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill - Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill - Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill - A transvaginal ultrasound to measure any ovarian follicles (optional procedure)


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06334315
Study type Interventional
Source Yale University
Contact Aaron M Lazorwitz, MD, PhD
Phone 2037854688
Email aaron.lazorwitz@yale.edu
Status Not yet recruiting
Phase Phase 4
Start date May 2024
Completion date May 2028

See also
  Status Clinical Trial Phase
Completed NCT02577601 - Impact of Combined Hormonal Contraceptives on UPA Phase 4
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Completed NCT04112095 - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use Phase 3
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Active, not recruiting NCT04291001 - Ovarian Function With ENG Implant and UPA Use Early Phase 1
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed NCT03438682 - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting NCT01948882 - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women N/A
Enrolling by invitation NCT04997499 - Adolescent Subcutaneous (SQ) Injection Video Validation N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03154125 - Sayana® Press Extension Study Phase 3
Withdrawn NCT03725358 - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon. N/A
Completed NCT02957630 - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" Phase 1/Phase 2
Completed NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
Recruiting NCT02121067 - LNG-IUS at 2 Weeks Postpartum Phase 4
Terminated NCT02169869 - Immediate Postplacental IUD Insertion N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Withdrawn NCT01930994 - Kenya Sino-implant (II) PK Study N/A