HealthyNCT00467805
Immediate Effect of Light on Reproductive Hormones in Women: a Role of the Spectrum
A study testing Light therapy in people with Healthy, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Light therapy
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2009to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-45 y
- normal (21-35 days) menstrual cycle
- good and stable general health
- normal body weight index 18.5-29.9
- normal sleep-wake regimen
- living close to the laboratory (<7' by walk)
- "good"cubital veins
Who cannot join
- difficulty to contact
- travel over several time zones during last month
- medications known to interfere with hormone release
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.
Read the detailed description
Sixteen healthy women came to the laboratory at 7:30 (wearing dark goggles) at two occasions (separated by 2-3 days, first time - at the 3rd-8th day of their menstrual cycle) to be exposed for 45' to white-appearing or red LED light (sequential allocation). The white light has a distinct peak at 460 nm, the narrow-band red light peaked at 651 nm. The LED devices were positioned at the distance of 50 cm (white) and 45 cm (red) from the eyes to be matched by irradiance (approximately 7.0 microWt/m2); background light in direction of gaze was 5-10 lux. Blood and saliva samples were collected before, in the middle, and during the last minutes of the 45' exposure to be measured later for concentration of luteinizing hormone, follicle-stimulating hormone, prolactin, estrogen, progesterone, and also - for cortisol and melatonin (the last one - in saliva) as well-studied indicators of the direct effect of light.
- Conditions
- Healthy
- Being tested
- Light therapy
- Keywords
- Light exposure, light spectrum, reproductive hormones, women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproductive hormones concentration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Konstantin V Danilenko, MD, Study chair, Institute of Internal Medicine SB RAMSOksana Y. Sergeeva, PhD student, Principal investigator, Institute of Internal Medicine SB RAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467805
- Sponsor's protocol ID
- M-s4c
- Status last verified
- Oct 2009
- First submitted
- 30 Apr 2007
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Light on Reproductive Hormones in Women: a Role of the Spectrum
- ClinicalTrials.gov ID
- NCT00467805
- Acronym / sponsor ID
- M-s4c
- Conditions
- Healthy
- Keywords
- Light exposure, light spectrum, reproductive hormones, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 1 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates an acute effect of white-appearing LED light (with a peak in blue portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.
Detailed description
Sixteen healthy women came to the laboratory at 7:30 (wearing dark goggles) at two occasions (separated by 2-3 days, first time - at the 3rd-8th day of their menstrual cycle) to be exposed for 45' to white-appearing or red LED light (sequential allocation). The white light has a distinct peak at 460 nm, the narrow-band red light peaked at 651 nm. The LED devices were positioned at the distance of 50 cm (white) and 45 cm (red) from the eyes to be matched by irradiance (approximately 7.0 microWt/m2); background light in direction of gaze was 5-10 lux. Blood and saliva samples were collected before, in the middle, and during the last minutes of the 45' exposure to be measured later for concentration of luteinizing hormone, follicle-stimulating hormone, prolactin, estrogen, progesterone, and also - for cortisol and melatonin (the last one - in saliva) as well-studied indicators of the direct effect of light.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 18-45 y
- normal (21-35 days) menstrual cycle
- good and stable general health
- normal body weight index 18.5-29.9
- normal sleep-wake regimen
Key exclusion criteria (3 listed)
- difficulty to contact
- travel over several time zones during last month
- medications known to interfere with hormone release
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light therapy | Procedure or surgery | – |
Primary outcome
Reproductive hormones concentration
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantin V Danilenko, MD study chair
Institute of Internal Medicine SB RAMS
Oksana Y. Sergeeva, PhD student principal investigator
Institute of Internal Medicine SB RAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy in people with Healthy, run by Russian Academy of Medical Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductive hormones concentration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2010.