ProgesteronePhase 1PK-PiPNCT03340701
Pharmacokinetics of Progesterone in Pregnancy
A Phase 1 study testing vaginal progesterone suppository in people with Progesterone, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Progesterone
- What is being tested?
- vaginal progesterone suppository
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 30 Jun 2018
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks
- pre-pregnancy BMI 20-40
- no history of prior preterm birth
Who cannot join
- history of an adverse reaction to progesterone
- contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone
- medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease
- major fetal anomaly diagnosed on ultrasound or known chromosomal disorder
- multifetal gestation
- vaginal bleeding, preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment or on Day 1 of study
Show all 12Show fewer
- any progesterone use of any form previously during the pregnancy
- active vaginitis
- Illicit substance use in pregnancy including cocaine, opiates, marijuana
- abnormal pap smear/+HPV on most recent pap smear
- known or suspected malignancy of the breast or genital organs
- cervical length ≤25mm
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Pharmacokinetics of Vaginal Progesterone in Pregnancy
Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation
Read the detailed description
Prospective study of 6 women with singleton pregnancies 18 0/7- 23 6/7 weeks' gestation with no prior preterm birth or short cervix who are administered a single dose of 200mg vaginal progesterone suppository. Serum progesterone levels will be drawn serially from pre-dose to 24 hours post-dose.
- Conditions
- Progesterone
- Being tested
- vaginal progesterone suppository
- Keywords
- progesterone, pharmacology, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal progesterone suppositoryDrug
200mg vaginal suppository micronized progesterone
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Progesterone | Other | micronized progesterone vaginal suppository 200mg Receives: Drug: vaginal progesterone suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic model
Plasma concentration time profile of vaginal progesterone in pregnant women.
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 posted13 Nov 2017
- Study start6 Nov 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProgesteroneStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pharmacokinetic study to assess plasma concentration time profile of vaginal progesterone in pregnant women.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rupsa C Boelig, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340701
- Sponsor's protocol ID
- 17D.559
- Acronym
- PK-PiP
- Status last verified
- Feb 2020
- First submitted
- 8 Nov 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boelig RC, Zuppa AF, Kraft WK, Caritis S. Pharmacokinetics of vaginal progesterone in pregnancy. Am J Obstet Gynecol. 2019 Sep;221(3):263.e1-263.e7. doi: 10.1016/j.ajog.2019.06.019. Epub 2019 Jun 15.
PubMed 31211965
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Vaginal Progesterone in Pregnancy
- ClinicalTrials.gov ID
- NCT03340701
- Acronym / sponsor ID
- PK-PiP / 17D.559
- Conditions
- Progesterone
- Keywords
- progesterone, pharmacology, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 13 Nov 2017 (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.
Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation
Detailed description
Prospective study of 6 women with singleton pregnancies 18 0/7- 23 6/7 weeks' gestation with no prior preterm birth or short cervix who are administered a single dose of 200mg vaginal progesterone suppository. Serum progesterone levels will be drawn serially from pre-dose to 24 hours post-dose.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pharmacokinetic study to assess plasma concentration time profile of vaginal progesterone in pregnant women.
| Arm | Type | Receives |
|---|---|---|
| Vaginal Progesterone | Other | Drug: vaginal progesterone suppositorymicronized progesterone vaginal suppository 200mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks
- pre-pregnancy BMI 20-40
- no history of prior preterm birth
Key exclusion criteria (12 listed)
- history of an adverse reaction to progesterone
- contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone
- medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease
- major fetal anomaly diagnosed on ultrasound or known chromosomal disorder
- multifetal gestation
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 |
|---|---|---|
| vaginal progesterone suppository200mg vaginal suppository micronized progesterone | Drug | Vaginal Progesterone |
Primary outcome
Pharmacokinetic model
Time frame: 24 hours
Plasma concentration time profile of vaginal progesterone in pregnant women.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Results publication: PubMed 31211965Boelig RC, Zuppa AF, Kraft WK, Caritis S. Pharmacokinetics of vaginal progesterone in pregnancy. Am J Obstet Gynecol. 2019 Sep;221(3):263.e1-263.e7. doi: 10.1016/j.ajog.2019.06.019. Epub 2019 Jun 15.
- Individual participant dataSharing planned: Undecided
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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.
Rupsa C Boelig, MD principal investigator
Thomas Jefferson University
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 vaginal progesterone suppository in people with Progesterone, 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 12 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 20 Feb 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic model (time frame: 24 hours). 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 NCT03340701, 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 20 Feb 2020.