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Effect of Bright Light on Sex Hormones and Ovulation in Humans

Primary Purpose

Anovulation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Light therapy
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anovulation focused on measuring Menstrual Cycle, Light Therapy, Sex Hormones, Ovulation

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age 19-40 years Mean menstrual cycle 28-38 days Good general health Generally normal sleep-wake regimen Motivated for free participation Exclusion Criteria: Low cooperation Medications known to interfere with hormone release Clinically evident endocrine abnormalities including the signs of Hyperandrogenism Travel over several time zones during two months prior the study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 17, 2006
    Last Updated
    October 18, 2009
    Sponsor
    Russian Academy of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00327366
    Brief Title
    Effect of Bright Light on Sex Hormones and Ovulation in Humans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Russian Academy of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study investigated whether bright artificial light may influence menstrual cycle and ovulation conclusively, and what underlying hormonal changes for this effect are.
    Detailed Description
    Several studies have shown a shortening of the menstrual cycle following light therapy in women with abnormally long menstrual cycles or with winter depression, which suggests that bright light may influence sex hormones and ovulation. The study was designed to investigate this possibility. Twenty-two women with slightly lengthened menstrual cycles and without clinically evident endocrine abnormalities completed a study lasting for two menstrual cycles separated by an off-protocol episode of at least 1 menstrual cycle. Bright light therapy was administered for a week at home during one experimental cycle, and dim light during another cycle (placebo-controlled, crossover, counter-balanced order). Daytime blood sampling and ultrasound scan were performed before and after a week of light therapy, on the ~7th and 14th days after menstruation onset. Ultrasound examination was repeated further to document ovulation. Serum was assayed for thyroid-stimulating hormone, prolactin, luteinizing hormone, follicle-stimulating hormone, and estradiol. The preliminary results were reported at the SLTBR meeting in June, 2005.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anovulation
    Keywords
    Menstrual Cycle, Light Therapy, Sex Hormones, Ovulation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Light therapy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 19-40 years Mean menstrual cycle 28-38 days Good general health Generally normal sleep-wake regimen Motivated for free participation Exclusion Criteria: Low cooperation Medications known to interfere with hormone release Clinically evident endocrine abnormalities including the signs of Hyperandrogenism Travel over several time zones during two months prior the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Konstantin V. Danilenko, MD
    Organizational Affiliation
    Institute of Internal Medicine SB RAMS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Bright Light on Sex Hormones and Ovulation in Humans

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