NCT00000295

Brief Summary

The purpose of this study is to investigate progesterone effects in female smokers

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1999

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

Study Start

First participant enrolled

April 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

January 12, 2017

Status Verified

April 1, 1999

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (3)

  • Behavioral

  • Subjective

  • Biochemical

Interventions

Micronized ProgesteroneDRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives.

You may not qualify if:

  • History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Dorothy Hatsukami, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

April 1, 1999

Study Completion

December 1, 2001

Last Updated

January 12, 2017

Record last verified: 1999-04

Locations

US(1)