PK-PiP: Pharmacokinetics of Progesterone in Pregnancy

Sponsor

Thomas Jefferson University (Other)

Overall Status

Completed

CT.gov ID

NCT03340701

Collaborator

(none)

Enrollment

Location

Arm

7.8

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Progesterone	Drug: vaginal progesterone suppository	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pharmacokinetic study to assess plasma concentration time profile of vaginal progesterone in pregnant women.Pharmacokinetic study to assess plasma concentration time profile of vaginal progesterone in pregnant women.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Pharmacokinetics of Vaginal Progesterone in Pregnancy

Actual Study Start Date :

Nov 6, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Vaginal Progesterone micronized progesterone vaginal suppository 200mg	Drug: vaginal progesterone suppository 200mg vaginal suppository micronized progesterone

Arm

Intervention/Treatment

Other: Vaginal Progesterone

micronized progesterone vaginal suppository 200mg

Drug: vaginal progesterone suppository

200mg vaginal suppository micronized progesterone

Outcome Measures

Primary Outcome Measures

Pharmacokinetic model [24 hours]
Plasma concentration time profile of vaginal progesterone in pregnant women.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator: Rupsa C Boelig, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT03340701

Other Study ID Numbers:

17D.559

First Posted:

Nov 13, 2017

Last Update Posted:

Feb 20, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Jefferson University

progesterone

pharmacology

pharmacokinetics

Additional relevant MeSH terms:

Progesterone

Study Results

No Results Posted as of Feb 20, 2020