Oral Contraceptive Pill (OCP) Pharmacogenomics
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorYale University
About this trial
The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how individual bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. The investigators are 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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Female, aged 18-45 years old
In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories.
Disqualifiers
Currently taking any known CYP3A inducers/inhibitors (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort)43
Any medical conditions that affect liver function (e.g., hepatitis, cirrhosis)
Contraindications to estrogen-containing contraception (based on category 3 or 4 recommendations in the CDC MEC guidelines42)
Current breast cancer or personal history of breast cancer
Trial design
Design model
Single group
Treatments tested in this trial
Desogestrel / Ethinyl Estradiol Pill
DrugStandard pill packs containing 21 active pills and 7 placebo pills
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: Combined oral contraceptive pill usersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serum etonogestrel concentration
Pharmacokinetic measurement for progestin
Time frame
Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days)2
Serum ethinyl estradiol concentration
Pharmacokinetic measurement for estrogen
Time frame
Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days)Secondary outcomes
1
Serum estradiol concentration
Pharmacodynamic measurement of endogenous estrogen
Time frame
Measured on Cycle 1, Day 22 (all participants), repeated measure in Cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)2
Serum progesterone concentration
Pharmacodynamic measurement of endogenous progesterone
Time frame
Measured on Cycle 1, Day 22 (all participants), repeated measure in Cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)3
Modified Hoogland score
Calculated based on serum estradiol, serum progesterone, and follicle-like structures. found on transvaginal ultrasound. Scores range from 1 to 5, with a higher score indicating a higher likelihood of pending ovulation with a score of 5 indicating suspected ovulation
Time frame
Measured on Cycle 1, Day 22 (optional study procedure) (each cycle is 28 days)4
Positive and Negative Affect Scheduled
Questionnaire designed to assess current affect. Scores range from 10-50 for positive affect items and 10-50 for negative affect items, with higher scores representing more positive affect or negative affect, respectively.
Time frame
Baseline measured at enrollment, repeat measurement at Cycle 1, Day 22 (all participants), repeated measurements again in Cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov