NCT03340701

Pharmacokinetics of Progesterone in Pregnancy

Pharmacokinetics of Vaginal Progesterone in Pregnancy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Progesterone

Interventions

Type	Name	Description
DRUG	vaginal progesterone suppository	200mg vaginal suppository micronized progesterone

Timeline

• Start date: 2017-11-06
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-11-13
• Last updated: 2020-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study