Hypoactive Sexual Desire Disorder (HSDD)NCT02070029
Acupuncture for Sexual Dysfunction
A study testing Acupuncture in people with Hypoactive Sexual Desire Disorder (HSDD) and Low Libido, run by TriHealth Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder (HSDD), Low Libido, Female Sexual Dysfunction (FSD)
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort
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.
Read the 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
- Being tested
- Acupuncture
- Keywords
- Female Sexual Dysfunction (FSD), Hypoactive Sexual Desire Disorder (HSDD), Low libido, Acupuncture
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (5)
Female Sexual Distress Scale (FSDS-R)
Determined by functional data points distributed at enrollment and 6 weeks:
Female Sexual Distress scale - revised (FSDS-R)
Measured: 6 weeks
Short Form-12 (SF-12)
Determined by functional data points distributed at enrollment and 6 weeks:
Short Form-12 (SF-12)
Measured: 6 weeks
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)
Measured: 6 weeks
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)
Measured: 6 weeks
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire Disorder (HSDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- TriHealth Medical Education Research Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070029
- Sponsor's protocol ID
- 12053
- Status last verified
- Feb 2014
- First submitted
- 26 Jan 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort
- ClinicalTrials.gov ID
- NCT02070029
- Acronym / sponsor ID
- 12053
- Keywords
- Female Sexual Dysfunction (FSD), Hypoactive Sexual Desire Disorder (HSDD), Low libido, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Collaborators
- TriHealth Medical Education Research Fund
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureAcupuncture 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 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 | Procedure or surgery | Acupuncture |
Primary outcome
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.
5 secondary outcomes
Female Sexual Distress Scale (FSDS-R)
Time frame: 6 weeks
Short Form-12 (SF-12)
Time frame: 6 weeks
Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)
Time frame: 6 weeks
World Health Organization Quality of Life- BREF (WHOQOL)
Time frame: 6 weeks
Patient Global Impression of Improvement (PGI-I)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
Related trials for Hypoactive Sexual Desire Disorder (HSDD)
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Hypoactive Sexual Desire Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Hypoactive Sexual Desire Disorder (HSDD) and Low Libido, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.