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Completed

NCT Number: NCT03340701

Pharmacokinetics of Progesterone in Pregnancy

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

vaginal progesterone suppository

Drug

200mg vaginal suppository micronized progesterone

Primary outcomes

  1. Pharmacokinetic model

    Time frame: 24 hours

    Plasma concentration time profile of vaginal progesterone in pregnant women.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Pharmacokinetics of Vaginal Progesterone in Pregnancy

Acronym: PK-PiP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2017
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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