Pharmacokinetics of Progesterone in Pregnancy

Phase 1

Completed

• Conditions: Progesterone
• Interventions: Drug: vaginal progesterone suppository

• Registration Number: NCT03340701
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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 Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-13
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal Progesterone	vaginal progesterone suppository	micronized progesterone vaginal suppository 200mg

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic model	24 hours	Plasma concentration time profile of vaginal progesterone in pregnant women.

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States