- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327366
Effect of Bright Light on Sex Hormones and Ovulation in Humans
October 18, 2009 updated by: Russian Academy of Medical Sciences
The study investigated whether bright artificial light may influence menstrual cycle and ovulation conclusively, and what underlying hormonal changes for this effect are.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Completion (ACTUAL)
April 1, 2006
Study Registration Dates
First Submitted
May 17, 2006
First Submitted That Met QC Criteria
May 17, 2006
First Posted (ESTIMATE)
May 18, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
October 19, 2009
Last Update Submitted That Met QC Criteria
October 18, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-s3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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