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Clinical Trial Summary

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.


Clinical Trial Description

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:

- An Initial Evaluation in which the certified acupuncturist will take a

- 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 pulse

- 25 minutes of resting quietly with acupuncture needles in place

- Needle usage: from8 to 20 needles are typically used, with an average of 14 per session

- Needles are typically placed on the scalp, lower abdomen, elbows and knees

Subsequent Sessions (9 more) with the certified acupuncturist

- 25 minute each, twice weekly, for 5 weeks = total 10 sessions

- Needle usage = 8-20, average 14 per session

- Typically placed on the scalp, lower abdomen, elbows and knees

The questionnaires/surveys include questions about:

- Sexual desire, arousal, lubrication, orgasm, satisfaction and pain

- General physical health

- General emotional and psychological health

- Social relationships ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02070029
Study type Interventional
Source TriHealth Inc.
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date June 2014

See also
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Completed NCT00349791 - Study to Assess the Efficacy/Safety of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido Phase 3
Completed NCT01702818 - Stress Hormones, Mood and Women's Sexual Desire (MODEST)