Phase 4
Completed N=22
Desogestrel-containing COCP Pharmacokinetic Validation Study
Source: ClinicalTrials.gov NCT05002738 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Serum Etonogestrel Concentrations — 0.92 correlation coefficient (r)
◆ Published Evidence
Not yet cited
0citations
Validation of 24-hour trough concentration as a proxy for intensive pharmacokinetic measurements for a combined oral contraceptive pill containing desogestrel.
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.
Linked Publications
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Validation of 24-hour trough concentration as a proxy for intensive pharmacokinetic measurements for a combined oral contraceptive pill containing desogestrel.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Etonogestrel Concentrations |
0.92 | — |
| PRIMARY Serum Ethinyl Estradiol Concentrations |
0.86 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05002738) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.