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OpenTrials
Completed

NCT Number: NCT02070029

Acupuncture for Sexual Dysfunction

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TriHealth

Cincinnati, Ohio, 45220, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Collaborators

  • TriHealth Medical Education Research Fund

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2014
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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