NCT00456222

Brief Summary

The purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

June 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

4.1 years

First QC Date

April 2, 2007

Last Update Submit

August 20, 2009

Conditions

SleepCircadian RhythmMenstrual Cycle

Keywords

SleepCircadian rhythmsMenstrual cycle

Study Arms (2)

Luteal

Behavioral: Disrupting or changing the timing or the duration of sleep

Follicular

Behavioral: Disrupting or changing the timing or the duration of sleep

Interventions

Disrupting or changing the timing or the duration of sleepBEHAVIORAL

Disrupting or changing the timing or the duration of sleep

FollicularLuteal

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy women with regular menstrual cycles

You may qualify if:

  • Healthy
  • Regular menstrual cycles

You may not qualify if:

  • No medications affecting the menstrual cycle or sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood/plasma

Study Officials

  • Elizabeth B Klerman, MD PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Janet E Hall, MD

    Massachusetts General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

June 1, 2003

Primary Completion

July 1, 2007

Study Completion

August 1, 2009

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

US(2)