ContraceptionPhase 4NCT06334315
Oral Contraceptive Pill (OCP) Pharmacogenomics
A Phase 4 study testing Desogestrel / Ethinyl Estradiol Pill in people with Contraception and Pharmacogenomic Drug Interaction, run by Yale University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Pharmacogenomic Drug Interaction
- What is being tested?
- Desogestrel / Ethinyl Estradiol Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2024to May 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Ability to take oral medication and be willing to adhere to the oral contraceptive pill (DSG/EE) regimen
- Body-mass index ≥18.5kg/m2
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- Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study
- Normal blood pressure measurement at study screening
- Negative urine pregnancy test at study screening
Who cannot join
- 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
- Severe decompensated cirrhosis
- Personal history of deep venous thrombosis or pulmonary embolism
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- Recent major surgery with prolonged immobilization
- Diabetes with nephropathy, retinopathy, neuropathy, or other vascular disease
- Current gallbladder disease
- Migraine headaches with aura
- History of malabsorptive bariatric surgery
- History of cholestasis due to past oral contraceptive pill use
- Personal history of hypertension
- Personal history of ischemic heart disease
- Known thrombogenic mutations
- Personal history of focal nodular hyperplasia of the liver, hepatocellular adenoma, or malignant hepatoma
- Multiple sclerosis with prolonged immobility
- History of peripartum cardiomyopathy
- Current tobacco smoker and age ≥35 years
- History of complicated solid organ transplantation
- Personal history of stroke
- Personal history of superficial venous thrombosis
- Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
- Complicated valvular heart disease
- Current use of fosamprenavir or lamotrigine
- Use of injectable contraceptive method within 6 months or current use of an ENG implant
- Childbirth within 6 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Araceli Cortez, 303-501-4157, ARACELI.2.CORTEZ@CUANSCHUTZ.EDU
- Recruiting
Yale University
New Haven, Connecticut, 06520
AmberJean Hansen, 203-737-7962, BirthControlGene@yale.edu
Aaron Lazorwitz, MD, PhD
About this study
Official title: Influence of Genetics Variants on the Pharmacokinetics and Pharmacodynamics of Combined Oral Contraceptive Pill Users
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?
Read more
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)
- Conditions
- Contraception, Pharmacogenomic Drug Interaction
- Being tested
- Desogestrel / Ethinyl Estradiol Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel / Ethinyl Estradiol PillDrug
Standard pill packs containing 21 active pills and 7 placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Combined oral contraceptive pill users | Experimental | 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) Receives: Drug: Desogestrel / Ethinyl Estradiol Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum etonogestrel concentration
Pharmacokinetic measurement for progestin
Measured: Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days)
Serum ethinyl estradiol concentration
Pharmacokinetic measurement for estrogen
Measured: Measured as a trough concentration on Cycle 1, Day 22 (each cycle is 28 days)
Secondary outcomes (6)
Serum estradiol concentration
Pharmacodynamic measurement of endogenous estrogen
Measured: Measured on Cycle 1, Day 22 (all participants), repeated measure in Cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)
Serum progesterone concentration
Pharmacodynamic measurement of endogenous progesterone
Measured: Measured on Cycle 1, Day 22 (all participants), repeated measure in Cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)
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
Measured: Measured on Cycle 1, Day 22 (optional study procedure) (each cycle is 28 days)
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.
Measured: 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)
Sex hormone binding globulin levels
Marker of estrogenicity
Measured: Baseline measured at enrollment, repeat measurement at Cycle 1, Day 22 (all participants), repeat measurements in cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)
Serum albumin concentration
Protein binding compound
Measured: Baseline measured at enrollment, repeat measurement at Cycle 1, Day 22 (all participants), repeat measurements in cycles 3, 6, and 13 (optional study procedures) (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start29 Oct 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Aaron M Lazorwitz, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334315
- Sponsor's protocol ID
- 2000037337
- Other IDs
- R01HD111436
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available to other researchers at the conclusion of this study and after publication of its findings. Data will be uploaded to dbGaP with individual-level data for genotypes and phenotypes collected in this study.