ContraceptionPhase 4NCT05002738
Desogestrel-containing COCP Pharmacokinetic Validation Study
A Phase 4 study testing Desogestrel and Ethinyl Estradiol Tablets in people with Contraception, run by University of Colorado, Denver at 1 site in United States.
Trial 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). 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
- What is being tested?
- Desogestrel and Ethinyl Estradiol Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 28 Nov 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Desogestrel and Ethinyl Estradiol Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel and Ethinyl Estradiol TabletsDrug
Combined oral contraceptive pill
| Study group | Role | What they receive |
|---|---|---|
| Overall Cohort | Experimental | Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days Receives: Drug: Desogestrel and Ethinyl Estradiol Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start10 Sep 2021
- Primary completion28 Nov 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002738
- Sponsor's protocol ID
- 21-3936
- Status last verified
- May 2025
- First submitted
- 4 Aug 2021
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lazorwitz A, Sheeder J. Validation of 24-hour trough concentration as a proxy for intensive pharmacokinetic measurements for a combined oral contraceptive pill containing desogestrel. Contraception. 2023 Oct;126:110093. doi: 10.1016/j.contraception.2023.110093. Epub 2023 Jun 16.
PubMed 37331464
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel
- ClinicalTrials.gov ID
- NCT05002738
- Acronym / sponsor ID
- 21-3936
- Conditions
- Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 28 Nov 2022 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Cohort | Experimental | Drug: Desogestrel and Ethinyl Estradiol TabletsCombined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desogestrel and Ethinyl Estradiol TabletsCombined oral contraceptive pill | Drug | Overall Cohort |
Primary outcome
Serum Etonogestrel Concentrations
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37331464Lazorwitz A, Sheeder J. Validation of 24-hour trough concentration as a proxy for intensive pharmacokinetic measurements for a combined oral contraceptive pill containing desogestrel. Contraception. 2023 Oct;126:110093. doi: 10.1016/j.contraception.2023.110093. Epub 2023 Jun 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desogestrel and Ethinyl Estradiol Tablets in people with Contraception, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Etonogestrel Concentrations (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.