TriHealth
Cincinnati, Ohio, 45220, United States
NCT Number: NCT02070029
Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized treatment for this condition. We know that alternative therapies such as acupuncture have been beneficial to women suffering from urinary incontinence, chronic lower back pain, and migraines. We hypothesize that the quality of life for premenopausal women with hypoactive sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and 1 week after the final acupuncture session as the method of analyzing our primary outcome.
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Notify Me18 year–55 year
Female
Interventional
Not applicable
Cincinnati, Ohio, 45220, United States
Each woman will receive experimental therapy with acupuncture twice a week for five weeks and complete a packet of validated questionnaires/surveys at the 1st visit in person and at week 6 by mail.
The acupuncture sessions include:
Subsequent Sessions (9 more) with the certified acupuncturist
The questionnaires/surveys include questions about:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acupuncture Therapy - Initial Evaluation History including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood.
Physical Exam: inspection of tongue and palpation of central and peripheral pulses.
Chinese Diagnoses for Female Sexual Dysfunction: Kidney Yang Deficiency; Liver Qi Stagnation; Generalized Blood Deficiency; Spleen Yang Deficiency; Heart Fire
Time frame: 6 weeks
Determined by a change in the desire domain of the Female Sexual Function Index (FSFI) from baseline at enrollment to study completion at 6 weeks after initiation of intervention.
Time frame: 6 weeks
Determined by functional data points distributed at enrollment and 6 weeks:
Female Sexual Distress scale - revised (FSDS-R)
Time frame: 6 weeks
Determined by functional data points distributed at enrollment and 6 weeks:
Short Form-12 (SF-12)
Time frame: 6 weeks
Determined by functional data points distributed at enrollment and 6 weeks:
Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)
Time frame: 6 weeks
Determined by functional data points distributed at enrollment and 6 weeks:
World Health Organization Quality of Life- BREF (WHOQOL)
Time frame: 6 weeks
Determined by functional data points distributed at enrollment and 6 weeks:
Patient Global Impression of Improvement (PGI-I)
TriHealth Inc.
Other
Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort
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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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