NCT00467805

Brief Summary

The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2009

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

April 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 9, 2010

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

April 30, 2007

Last Update Submit

April 8, 2010

Conditions

Healthy

Keywords

Light exposurelight spectrumreproductive hormoneswomen

Outcome Measures

Primary Outcomes (1)

  • Reproductive hormones concentration

    3 months

Interventions

Light therapyPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-45 y
  • normal (21-35 days) menstrual cycle
  • good and stable general health
  • normal body weight index 18.5-29.9
  • normal sleep-wake regimen
  • living close to the laboratory (\<7' by walk)
  • "good"cubital veins

You may not qualify if:

  • difficulty to contact
  • travel over several time zones during last month
  • medications known to interfere with hormone release

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Internal Medicine SB RAMS

Novosibirsk, 630089, Russia

Location

MeSH Terms

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Konstantin V Danilenko, MD

    Institute of Internal Medicine SB RAMS

    STUDY CHAIR

  • Oksana Y. Sergeeva, PhD student

    Institute of Internal Medicine SB RAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 1, 2007

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

October 1, 2009

Last Updated

April 9, 2010

Record last verified: 2009-10

Locations

RU(1)