Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334315
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-03-13
Brief Title:
Oral Contraceptive Pill OCP Pharmacogenomics
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Influence of Genetics Variants on the Pharmacokinetics and Pharmacodynamics of Combined Oral Contraceptive Pill Users
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 CYP3A71C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill
Do individuals with the CYP3A71C variant experience higher rates of breakthrough ovulation while taking a desogestrelethinyl 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 desogestrelethinyl 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
Do individuals with the CYP3A71C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill
Do individuals with the CYP3A71C variant experience higher rates of breakthrough ovulation while taking a desogestrelethinyl 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 desogestrelethinyl 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD111436 | NIH | NIH | None |