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CompletedNCT03340701PK-PiPUpdated Feb 20, 2020

Pharmacokinetics of Progesterone in Pregnancy

A Phase 1 interventional study of vaginal progesterone suppository in Progesterone, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Thomas Jefferson University · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jun 2018, 8 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Progesterone

Keywords

  • progesterone
  • pharmacology
  • pharmacokinetics
03

In context

Lead sponsor

Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.

Browse Thomas Jefferson University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks
  • pre-pregnancy 20-40
  • no history of prior preterm birth

Exclusion criteria

Exclusion Criteria:

  • history of an adverse reaction to progesterone
  • 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
  • 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 of the breast or genital organs
  • cervical length ≤25mm
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Other
    Vaginal Progesterone

    micronized progesterone vaginal suppository 200mg

    Drug: vaginal progesterone suppository

Interventions

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic model

    Plasma concentration time profile of vaginal progesterone in pregnant women.

    Time frame: 24 hours

07

Study locations

1 site
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Jun 2018, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2017
First posted
Nov 13, 2017
StartActual
Nov 6, 2017
Primary completionActual
Jun 30, 2018
CompletionActual
Jun 30, 2018
Last update
Feb 20, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03340701
Lead sponsor
Thomas Jefferson University
Responsible party
Sponsor
First posted
Nov 13, 2017
Start date
Nov 6, 2017
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Feb 20, 2020

Study contacts

Rupsa C Boelig, MD
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Progesterone

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