Pharmacokinetics of Progesterone in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing IM vs. Vaginal Progesterone for Pre-term Birth

NCT00579553

Infant, Premature Premature Birth

COMPLETED NA

Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

NCT02913495

Premature Birth

COMPLETED PHASE4

Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

NCT00329914

Preterm Delivery

COMPLETED PHASE2

Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

NCT03781674

Twin; Pregnancy, Affecting Fetus or Newborn

UNKNOWN NA

Progesterone in Patients With Placenta Previa

NCT03633175

Placenta Previa

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Progesterone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaginal Progesterone

micronized progesterone vaginal suppository 200mg

Group Type OTHER

vaginal progesterone suppository

Intervention Type DRUG

200mg vaginal suppository micronized progesterone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vaginal progesterone suppository

200mg vaginal suppository micronized progesterone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes