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Completed

NCT Number: NCT01697085

Effects of Sea Buckthorn Oil on Mucous Membranes

Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes

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Key information

Conditions

Mucous Membranes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turun Gynekologikeskus

Turku, 20100, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women experiencing vaginal dryness
  • 55-75 years of age
  • at least 12 months from menstruation

Exclusion criteria

  • use of estrogen replacement therapy

Treatment and study plan

Sea buckthorn oil

Dietary Supplement

Placebo oil

Dietary Supplement

Primary outcomes

  1. Change from baseline in dryness related symptoms of genital mucous membranes

    Time frame: Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)

    Interview for symptom score at baseline and study visits and a daily symptom logbook during the intervention

Secondary outcomes

  1. Change from baseline in vaginal pH

    Time frame: At baseline, at 3 months (end of intervention)

Other outcomes

  1. Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation

    Time frame: At baseline, at 3 months (end of intervention)

    • Vaginal health index: index score, change from baseline
    • Vaginal dryness: moistening of pH test strip, change from baseline
    • Vaginal maturity index: change from baseline
    • Symptoms of dryness in other mucous membranes: daily symptom logbook during the intervention
    • Markers of inflammation, oxidative stress and metabolic disorders: analysis from serum/plasma, change from baseline

Sponsors and collaborators

Lead sponsor

Aromtech Ltd.

Industry

Collaborators

  • The Finnish Funding Agency for Technology and Innovation

Registry information

Acronym: SBMM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 2, 2012
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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