NCT03340701

Brief Summary

Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

November 8, 2017

Last Update Submit

February 18, 2020

Conditions

Progesterone

Keywords

progesteronepharmacologypharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic model

    Plasma concentration time profile of vaginal progesterone in pregnant women.

    24 hours

Study Arms (1)

Vaginal Progesterone

OTHER

micronized progesterone vaginal suppository 200mg

Drug: vaginal progesterone suppository

Interventions

vaginal progesterone suppositoryDRUG

200mg vaginal suppository micronized progesterone

Vaginal Progesterone

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly women, study in pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 31211965RESULT

Study Officials

  • Rupsa C Boelig, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pharmacokinetic study to assess plasma concentration time profile of vaginal progesterone in pregnant women.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 13, 2017

Study Start

November 6, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

US(1)