NCT02070029

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 17, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

January 26, 2014

Last Update Submit

October 15, 2014

Conditions

Hypoactive Sexual Desire Disorder (HSDD)Low LibidoFemale Sexual Dysfunction (FSD)

Keywords

Female Sexual Dysfunction (FSD)Hypoactive Sexual Desire Disorder (HSDD)Low libidoAcupuncture

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Female Sexual Distress Scale (FSDS-R)

    6 weeks

  • Short Form-12 (SF-12)

    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)

    6 weeks

  • Patient Global Impression of Improvement (PGI-I)

    6 weeks

Study Arms (1)

Acupuncture

EXPERIMENTAL

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

Interventions

AcupuncturePROCEDURE

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

Acupuncture

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2014

First Posted

February 24, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 17, 2014

Record last verified: 2014-02

Locations

US(1)