Acupuncture for Sexual Dysfunction

Hypoactive Sexual Desire Disorder (HSDD) Clinical Trial

Official title:

Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070029
• Other study ID #: 12053
• Status: Completed
• Phase: N/A
• First received: January 26, 2014
• Last updated: October 15, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: February 2014
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women aged 18-55 years

• Sexually Active

• Premenopausal

• Documented diagnosis of HSDD as primary cause of FSD (defined as a non adjusted score of = 6 in the desire domain of the FSFI questionnaire)

Exclusion Criteria:

• Postmenopausal, defined as absence of menstruation in the prior 12 months

• Pain or dyspareunia as the primary cause of FSD (defined as a non adjusted score of = 6 in the pain domain of the FSFI)

• History of hysterectomy and/or oophorectomy

• History of chemotherapy, or pelvic irradiation

• Use of hormonal contraception or oral hormone replacement therapy

• Active skin infection or disease

• Blood dyscrasia

• Allergy to acupuncture needles

Study Design

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

Related Conditions & MeSH terms

• Female Sexual Dysfunction (FSD)
• Hypoactive Sexual Desire Disorder (HSDD)
• Hypokinesia
• Low Libido
• Sexual Dysfunctions, Psychological

Intervention

Procedure:
• Acupuncture
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 - Subsequent Sessions 25 minute sessions, 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

Locations

Country	Name	City	State
United States	TriHealth	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
TriHealth Inc.	TriHealth Medical Education Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual Function Index (FSFI)	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.	6 weeks	No
Secondary	Female Sexual Distress Scale (FSDS-R)	Determined by functional data points distributed at enrollment and 6 weeks: Female Sexual Distress scale - revised (FSDS-R)	6 weeks	No
Secondary	Short Form-12 (SF-12)	Determined by functional data points distributed at enrollment and 6 weeks: Short Form-12 (SF-12)	6 weeks	No
Secondary	Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)	Determined by functional data points distributed at enrollment and 6 weeks: Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)	6 weeks	No
Secondary	World Health Organization Quality of Life- BREF (WHOQOL)	Determined by functional data points distributed at enrollment and 6 weeks: World Health Organization Quality of Life- BREF (WHOQOL)	6 weeks	No
Secondary	Patient Global Impression of Improvement (PGI-I)	Determined by functional data points distributed at enrollment and 6 weeks: Patient Global Impression of Improvement (PGI-I)	6 weeks	No