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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00327366
Other study ID # M-s3
Secondary ID
Status Completed
Phase N/A
First received May 17, 2006
Last updated October 18, 2009
Start date September 2003
Est. completion date April 2006

Study information

Verified date October 2009
Source Russian Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study investigated whether bright artificial light may influence menstrual cycle and ovulation conclusively, and what underlying hormonal changes for this effect are.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 40 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
Light therapy


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Russian Academy of Medical Sciences
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