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
About this trial
This is an interventional basic science trial for Anovulation focused on measuring Menstrual Cycle, Light Therapy, Sex Hormones, Ovulation
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00327366
First Posted
May 17, 2006
Last Updated
October 18, 2009
Sponsor
Russian Academy of Medical Sciences
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
Learn more about this trial
Effect of Bright Light on Sex Hormones and Ovulation in Humans
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