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NCT01811225 · ClinicalTrials.gov registry record · Phase 2

Smoking, Sex Hormones, and Pregnancy

A Phase 2 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 2
Development phase
95
Enrollment target

NCT01811225: Completed Phase 2 study, sponsored by University of Minnesota.

NCT01811225 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01811225, a Phase 2 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
95 participants
Enrollment target

Study Summary

The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence

Primary Outcome

Questionnaire on Smoking Urges-Brief (QSU-Brief): This ten-item version of the original form (QSU) was developed by Tiffany and Drobes and has an excellent level of reliability (α = .97). Total QSU-Brief. Scores can average between 1-7. A higher scores means more urges.

Interventions

  • DRUG Low-dose Progesterone
  • DRUG High-dose Progesterone

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2012-12
Est. Completion 2017-06
Phase Phase 2
University of Minnesota

966 total trials

What the finished NCT01811225 record still lists

NCT01811225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 2 interventions - of which Low-dose Progesterone is the first listed.

NCT01811225 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01811225 about?

NCT01811225 is a clinical study titled "Smoking, Sex Hormones, and Pregnancy". The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the chan...

What is the current status of trial NCT01811225?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2012-12. Estimated completion is 2017-06.

What interventions are being tested in trial NCT01811225?

The interventions under investigation include: Low-dose Progesterone (DRUG), High-dose Progesterone (DRUG).

Who is sponsoring clinical trial NCT01811225?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01811225's enrollment target sits among peer trials

95 759th of 2000 higher than 1,237 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01811225, the US trial registry maintained by the National Library of Medicine. NCT01811225 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.