Pharmacokinetics of Progesterone in Pregnancy

Pharmacokinetics of Vaginal Progesterone in Pregnancy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03340701

Acronym

PK-PiP

Enrollment

Registered

2017-11-13

Start date

2017-11-06

Completion date

2018-06-30

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progesterone

Keywords

progesterone, pharmacology, pharmacokinetics

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.

Interventions

DRUGvaginal progesterone suppository

200mg vaginal suppository micronized progesterone

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026