Contraception
Conditions
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.
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.
Interventions
DRUGDesogestrel and Ethinyl Estradiol Tablets
Combined oral contraceptive pill
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Etonogestrel Concentrations | 24 hours | 12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve versus 24-hour trough measurement |
| Serum Ethinyl Estradiol Concentrations | 24 hours | 12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve to 24-hour trough measurements |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Cohort Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Overall Cohort | — |
|---|---|---|
| Age, Continuous | 28.3 years | — |
| Body-mass index | 24.8 kg/m^2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 20 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Serum Ethinyl Estradiol Concentrations
12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve to 24-hour trough measurements
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Serum Ethinyl Estradiol Concentrations | 0.86 correlation coefficient (r) |
Primary
Serum Etonogestrel Concentrations
12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve versus 24-hour trough measurement
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Cohort | Serum Etonogestrel Concentrations | 0.92 correlation coefficient (r) |