Effect of Bright Light on Sex Hormones and Ovulation in Humans

NCT ID: NCT00327366

Last Updated: 2009-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-04-30

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.

Conditions

Anovulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Interventions

Light therapy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Russian Academy of Medical Sciences

OTHER

Sponsor Role: lead

Principal Investigators

Konstantin V. Danilenko, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Internal Medicine SB RAMS

Other Identifiers

M-s3

Identifier Type: -

Identifier Source: org_study_id