NCT01798394

Brief Summary

The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 9, 2017

Completed
Last Updated

January 9, 2017

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

February 21, 2013

Results QC Date

July 26, 2016

Last Update Submit

November 10, 2016

Conditions

Tobacco Use CessationTobacco Use Disorder

Keywords

pregnantsmokercigarettetobacco

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Relapsed by Week 4 Postpartum

    Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.

    Week 4 Postpartum

Secondary Outcomes (6)

  • Number of Participants Who Relapsed by Week 12 Postpartum

    Week 12 Postpartum

  • Number of Participants Who Relapsed at All During Postpartum (up to Day 84)

    Postpartum Day 0 to 84

  • Protocol Compliance - Number of Visits Attended

    Gestational Week 36 - Postpartum Week 12

  • Compliance Determinants

    Postpartum Week 12

  • Protocol Compliance - Doses of Medication Taken

    Postpartum Week 0 - Week 12

  • +1 more secondary outcomes

Study Arms (2)

Progesterone

ACTIVE COMPARATOR

Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Other: Placebo

Interventions

ProgesteroneDRUG

Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Also known as: Prometrium
Progesterone
PlaceboOTHER

Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Woman
  • years old
  • Zero CPD for past 4 weeks
  • or more CPD for at least 6 out of past 12 months
  • Motivated to remain abstinent (7 or higher out of 10)
  • Stable physical/mental health
  • Established prenatal care
  • Stable physical/mental health
  • Willing to take Progesterone
  • Willing to use double-barrier protection if sexually active
  • English fluency
  • Able to provide informed consent

You may not qualify if:

  • Psychotropic medications
  • Illicit drugs
  • Other types of tobacco, NRT, smoking cessation medications
  • Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of \>2 miscarriages)
  • Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors
  • History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota, 717 Delaware Street SE

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use Disorder

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Results Point of Contact

Title
Nicole Tosun
Organization
University of Minnesota
tosun004@umn.edu
612-624-5439

Study Officials

  • Sharon S. Allen, M.D., Ph.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

January 9, 2017

Results First Posted

January 9, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)