Pharmacokinetics of Progesterone in Pregnancy

Progesterone Clinical Trial

— PK-PiP  

Official title:

Pharmacokinetics of Vaginal Progesterone in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340701
• Other study ID #: 17D.559
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2020
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Progesterone

Intervention

Drug:
• vaginal progesterone suppository
200mg vaginal suppository micronized progesterone

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic model	Plasma concentration time profile of vaginal progesterone in pregnant women.	24 hours