Desogestrel-containing COCP Pharmacokinetic Validation Study

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05002738
Collaborator
(none)
20
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1
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Study Details

Study Description

Brief Summary

This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of area under the curve (gold standard pharmacokinetics). The original pharmacokinetic studies were performed with a levonorgestrel-containing oral contraceptive pill and we aim to duplicate those findings with a desogestrel-containing oral contraceptive pill.

Condition or Disease Intervention/Treatment Phase
  • Drug: Desogestrel and Ethinyl Estradiol Tablets
Phase 4

Detailed Description

Enrolled participants will be started on a standard pack of desogestrel-containing oral contraceptive pills and undergo an intensive pharmacokinetic study visit on day 21 of the pill pack. This will entail 11 serial blood draws and a final blood draw the next day at 24 hours post-pill intake to measure and calculate a pharmacokinetic area under the curve for both the estrogen and progestin components of the pill. We will then correlate the 24-hour trough measurement to the area under the curve measures to determine the correlation of these measurements.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel
Actual Study Start Date :
Sep 10, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Overall Cohort

Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days

Drug: Desogestrel and Ethinyl Estradiol Tablets
Combined oral contraceptive pill

Outcome Measures

Primary Outcome Measures

  1. Serum etonogestrel concentrations [24 hours]

    12 serum measurements taken over the course of 24 hours

  2. Serum ethinyl estradiol concentrations [24 hours]

    12 serum measurements taken over the course of 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy females aged 18-45 years

  • Body-mass index ≥18.5kg/m2

  • Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study

  • Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg)

  • Negative urine pregnancy test at screening

Exclusion Criteria:
  • Currently taking any known CYP3A4 inducers/inhibitors

  • Medical conditions that affect liver function (e.g. hepatitis, cirrhosis)

  • Any contraindications to estrogen-containing contraception (based on any category 3 or 4 recommendations from the CDC MEC guidelines)

  • Use of an injectable contraceptive method within the last 6 months or current use of an ENG contraceptive implant

  • Childbirth within the last 6 months

  • Known allergy or insensitivity to combined oral contraceptive pills

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Denver Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05002738
Other Study ID Numbers:
  • 21-3936
First Posted:
Aug 12, 2021
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022