Pharmacokinetics of Progesterone in Pregnancy (PK-PiP)

T

Thomas Jefferson University

Status and phase

Completed
Phase 1

Conditions

Progesterone

Treatments

Drug: vaginal progesterone suppository

Study type

Interventional

Funder types

Other

Identifiers

NCT03340701
17D.559

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Vaginal Progesterone
Other group
Description:
micronized progesterone vaginal suppository 200mg
Treatment:
Drug: vaginal progesterone suppository

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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