Pregnancy RelatedPhase 1PiP-2NCT04753957
Pharmacokinetics of Progesterone in Pregnancy-2
A Phase 1 study testing micronized Progesterone in people with Pregnancy Related, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- micronized Progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2022to 1 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥18yo
- Singleton gestation, ≥36 0/7 weeks gestation
- Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate
Who cannot join
- Contraindication to vaginal progesterone suppository
- Active hepatic disease
- Prior or current thrombus
- Known adverse reaction to progesterone
- Peanut allergy
- Bleeding disorder (such as thrombophilia)
Show all 10Show fewer
- Use of 17-hydroxyprogesterone caproate in the pregnancy
- Use of vaginal progesterone in the pregnancy
- History of adverse reaction to progesterone
- Current vaginitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
Read the detailed description
The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
- Conditions
- Pregnancy Related
- Being tested
- micronized Progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronized ProgesteroneDrug
200mg micronized progesterone placed vaginally
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone | Active comparator | 200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery Receives: Drug: micronized Progesterone |
| Control | No intervention | No intervention, scheduled cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial (ng/mg) progesterone time/concentration profile
Concentration of progesterone in endometrium, sampled at time of scheduled c-section
Measured: 12 hours
Plasma (ng/ml) progesterone time/concentration profile
concentration of serum progesterone, sampled at time of scheduled c-section
Measured: 12 hours
Secondary outcomes (1)
Side effect survey
survey of side effects
Measured: 24hr after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start7 Jan 2022
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Why it stopped: Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753957
- Sponsor's protocol ID
- 20D.1094
- Acronym
- PiP-2
- Status last verified
- May 2022
- First submitted
- 9 Feb 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may be requested following trial completion and publication with appropriate data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Progesterone in Pregnancy-2
- ClinicalTrials.gov ID
- NCT04753957
- Acronym / sponsor ID
- PiP-2 / 20D.1094
- Conditions
- Pregnancy Related
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
Detailed description
The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone | Active comparator | Drug: micronized Progesterone200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery |
| Control | No intervention | –No intervention, scheduled cesarean delivery |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age ≥18yo
- Singleton gestation, ≥36 0/7 weeks gestation
- Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate
Key exclusion criteria (10 listed)
- Contraindication to vaginal progesterone suppository
- Bleeding disorder (such as thrombophilia)
- Use of 17-hydroxyprogesterone caproate in the pregnancy
- Use of vaginal progesterone in the pregnancy
- History of adverse reaction to progesterone
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 |
|---|---|---|
| micronized Progesterone200mg micronized progesterone placed vaginally | Drug | Vaginal progesterone |
Primary outcome
Endometrial (ng/mg) progesterone time/concentration profile
Time frame: 12 hours
Concentration of progesterone in endometrium, sampled at time of scheduled c-section
Plasma (ng/ml) progesterone time/concentration profile
Time frame: 12 hours
concentration of serum progesterone, sampled at time of scheduled c-section
1 secondary outcome
Side effect survey
Time frame: 24hr after delivery
Results and safety
The study was stopped early (reason given: Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Yes. IPD may be requested following trial completion and publication with appropriate data sharing agreement.
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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 1 study testing micronized Progesterone in people with Pregnancy Related, run by Thomas Jefferson University 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 May 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.). Results are not available in the source record.
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?
Endometrial (ng/mg) progesterone time/concentration profile (time frame: 12 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?
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 26 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.