Trial record 3 of 246 for:    female sexual dysfunction

Acupuncture for Sexual Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by TriHealth Inc.
Sponsor:
Collaborator:
TriHealth Medical Education Research Fund
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT02070029
First received: January 26, 2014
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Hypoactive Sexual Desire Disorder (HSDD)
Low Libido
Female Sexual Dysfunction (FSD)
Procedure: Acupuncture

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Female Sexual Function Index (FSFI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Female Sexual Distress Scale (FSDS-R) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Determined by functional data points distributed at enrollment and 6 weeks:

    Female Sexual Distress scale - revised (FSDS-R)


  • Short Form-12 (SF-12) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Determined by functional data points distributed at enrollment and 6 weeks:

    Short Form-12 (SF-12)


  • Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Determined by functional data points distributed at enrollment and 6 weeks:

    Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)


  • World Health Organization Quality of Life- BREF (WHOQOL) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Determined by functional data points distributed at enrollment and 6 weeks:

    World Health Organization Quality of Life- BREF (WHOQOL)


  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    Determined by functional data points distributed at enrollment and 6 weeks:

    Patient Global Impression of Improvement (PGI-I)



Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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


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
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070029

Contacts
Contact: Susan H Oakley, MD 513-862-7265 susan_oakley@trihealth.co
Contact: Vivian Ghodsi, RN 513-853-4213 vivian_ghodsi@trihealth.com

Locations
United States, Ohio
TriHealth Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Susan H Oakley, MD    513-862-7265    susan_oakley@trihealth.com   
Contact: Vivian Ghodsi, RN    513-853-4213    vivian_ghodsi@trihealth.com   
Principal Investigator: Susan H Oakley, MD         
Sponsors and Collaborators
TriHealth Inc.
TriHealth Medical Education Research Fund
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02070029     History of Changes
Other Study ID Numbers: 12053
Study First Received: January 26, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
Female Sexual Dysfunction (FSD)
Hypoactive Sexual Desire Disorder (HSDD)
Low libido
Acupuncture

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014