Pharmacokinetics of Progesterone in Pregnancy | NCT03340701

Studies
Pharmacokinetics of Progesterone in Pregnancy

NCT03340701

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Feb 20, 2020Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Progesterone

Interventions

vaginal progesterone suppository

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 6, 2017Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Nov 8, 2017

First Submission Date that Met QC Criteria

Nov 9, 2017

First Posted Date

Nov 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2020

Last Update Posted Date

Feb 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal Progesterone	Other	micronized progesterone vaginal suppository 200mg	Drug: vaginal progesterone suppository

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaginal progesterone suppository	Drug	200mg vaginal suppository micronized progesterone	Vaginal Progesterone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

only women, study in pregnancy

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rupsa C Boelig, MD	Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University Hospital		Philadelphia	Pennsylvania	19107	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31211965	Result	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.