- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02070029
Acupuncture for Sexual Dysfunction
Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort
Study Overview
Status
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- TriHealth
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture
Acupuncture Therapy - twice weekly sessions for 5 weeks: 1st session 60 minutes with remaining 9 session approximately 45 minutes each. Physical exam at 1st session includes evaluation of peripheral pulses, head, neck, throat/tongue. No pelvic exam required. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Female Sexual Function Index (FSFI)
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Female Sexual Distress Scale (FSDS-R)
Time Frame: 6 weeks
|
Determined by functional data points distributed at enrollment and 6 weeks: Female Sexual Distress scale - revised (FSDS-R) |
6 weeks
|
Short Form-12 (SF-12)
Time Frame: 6 weeks
|
Determined by functional data points distributed at enrollment and 6 weeks: Short Form-12 (SF-12) |
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: Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9) |
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: World Health Organization Quality of Life- BREF (WHOQOL) |
6 weeks
|
Patient Global Impression of Improvement (PGI-I)
Time Frame: 6 weeks
|
Determined by functional data points distributed at enrollment and 6 weeks: Patient Global Impression of Improvement (PGI-I) |
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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