Hypoactive Sexual Desire DisorderPhase 2NCT02419209
The Effect of Individualised Homeopathic Treatment on Low Sexual Desire in Perimenopause
A Phase 2 study testing Sucrose pillules medicated with the Individualised Homeopathic Remedy in people with Hypoactive Sexual Desire Disorder, run by University of Johannesburg at 1 site in South Africa.
Trial summary
Low sexual desire, or decreased libido, is one of the most prevalent sexual complaints in females. Menopause is defined as the physiologic cessation of menses brought on by a decrease in ovarian function and is established once menses have been absent for at least twelve months. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Sucrose pillules medicated with the Individualised Homeopathic Remedy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2015to Oct 2015
- Phase
- Phase 2
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 40-60 years who are perimenopausal (up to one year after final menses)
- Low sexual desire present for the last 3 months
- At least 2 of the additional common signs and symptoms of perimenopause present for the last 3 months such as menorrhagia, irregular menses, amenorrhoea, hot flushes, night sweats, heart palpitations, insomnia, fatigue, mood swings, irritability, anxiety, memory and/or concentration loss, headaches, joint pain and vaginal dryness
- History of normal libido, with onset of low sexual desire coinciding with or appearing after the onset of other symptoms of perimenopause.
Who cannot join
- Cessation of menses for more than 1 year (postmenopause)
- Total hysterectomy
- Early menopause (before age 40)
- Pelvic or abdominal surgery in the preceding 6 months
- Pregnant or lactating women or childbirth in the preceding 12 months
- Gynaecological disorders such as endometriosis, uterine fibroids, dyspareunia or vaginismus
- Chronic diseases that affect sexual desire
- Chronic medication that can affect sexual desire such as: Hormone Replacement Therapy, oral contraceptives, anti-depressants, benzodiazepines, beta-blockers, opioids, carbamazepine or antihistamines.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2028
About this study
Low sexual desire, or decreased libido, is one of the most prevalent sexual complaints in females. Menopause is defined as the physiologic cessation of menses brought on by a decrease in ovarian function and is established once menses have been absent for at least twelve months. Perimenopause refers to the period shortly before as well as the twelve months after the last menstrual period. The duration of perimenopause varies greatly and signs and symptoms usually begin appearing during a woman's forties. A longitudinal study conducted in Seattle showed that women experienced a significant reduction in sexual desire during the late perimenopausal and early postmenopausal stages, with the biggest decline in sexual desire occurring from three years prior to two years after the final menstrual period. Despite being a prevalent female complaint, currently no standard treatment for low sexual desire exists. Homeopathy may offer a safe and effective solution for this common problem, however limited research has been conducted to date.
The aim of this study is to explore the effect of individualised homeopathic treatment on low sexual desire in perimenopausal females using detailed case studies, the desire and arousal subscales of the Female Sexual Function Index (FSFI) as well as Item 13 of the Female Sexual Distress Scale - Revised (FSDS-R).
Read the detailed description
This study is an embedded mixed method case study design and will take place at the University of Johannesburg Homeopathic Health Centre, Doornfontein Campus, over a period of twelve weeks. These twelve weeks will consist of four consultations per participant at four week intervals. Ten female participants aged 40-60 years who meet the inclusion criteria will be recruited by means of advertisements placed at the University of Johannesburg Doornfontein Campus as well as at pharmacies and health shops in the Gauteng area (with relevant permission given).
Once the volunteers agree to participate in the study, they will be requested to sign a Participant Information and Consent Form at the start of the initial consultation. Participants will also be requested to complete a screening questionnaire in order to determine whether they meet the inclusion and exclusion criteria. A complete case history will be taken for each participant who fits the inclusion criteria, using a detailed homeopathic case-taking form; vital signs will be checked and any necessary physical examinations will be performed. Participants will also complete the relevant Female Sexual Function Index (FSFI) subscales and Item 13 of the Female Sexual Distress Scale- Revised (FSDS-R).
The appropriate individualised homeopathic remedy for each participant will be selected using Mercurius Repertorisation Software Complete Repertory 2014 and the appropriate homeopathic Materia Medicas, under supervision of the attending clinician. At the follow-up consultations the case will be re-taken and the homeopathic medicine will either be repeated or changed based on the response of the participant to the medication previously administered following the principles of homeopathic prescribing. A relevant physical exam will be conducted, and participants will complete the relevant subscales of the FSFI and item 13 of the FSDS-R at each of the four consultations.
All data will be collected by the researcher during the course of the study. Qualitative data obtained from detailed case-takings will be used to write descriptive case studies. The FSFI subscales and FSDS-R Item 13 will be used to assess changes in desire and arousal across time and will be represented graphically. Due to the small sample size and qualitative nature of the cases no statistical analysis will be completed.
The outcome of this study may possibly indicate the effectiveness of individualised homeopathic treatment in low sexual desire associated with perimenopause. This study may provide the groundwork for future research on the effect of homeopathy on low sexual desire in females.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Sucrose pillules medicated with the Individualised Homeopathic Remedy
- Keywords
- Low sexual desire, Perimenopause, Homeopathy, Hypoactive Sexual Desire Disorder
- 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.
Sucrose pillules medicated with the Individualised Homeopathic RemedyOther
Sucrose pillules medicated with the Individualised Homeopathic Remedy and potency as selected by the researcher in accordance with the laws that govern individualised homeopathic prescribing.
| Study group | Role | What they receive |
|---|---|---|
| Individualised Homeopathic Remedy | Experimental | A single individualised homeopathic remedy will be administered to each participant in the form of medicated sucrose pillules. The potency, dosage and frequency of administration will be individualised for each participant in accordance with the laws that govern homeopathic prescribing. Receives: Other: Sucrose pillules medicated with the Individualised Homeopathic Remedy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index
The Female Sexual Function Index (FSFI) covers six domains of female sexual function namely: desire, subjective arousal, lubrication, orgasm, satisfaction and pain. The study has shown a high test-retest reliability and a high degree of internal consistency for each of the six domains.
Measured: Every fourth week for twelve weeks.
Secondary outcomes (2)
The Female Sexual Distress Scale (FSDS-R)
The FSDS-R can be used to identify distress related to sexual function, as well as to support a potential diagnosis of sexual dysfunction. It has demonstrated the discriminant validity and test-retest reliability of both the FSDS-R and FSDS-R Item 13 alone in women suffering from Hypoactive Sexual Desire Disorder. Item 13 of the scale specifically pertains to low sexual desire and has been demonstrated to have good content validity, thereby making it sufficient as a stand-alone measure for low sexual desire.
Measured: Every fourth week for twelve weeks.
Individual participant case histories
Individual case histories of each participant will be recorded during each consultation, by means of the researcher's case notes, in order to collect qualitative data.
Measured: Every fourth week for twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Janice Pellow, M.TechHom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419209
- Sponsor's protocol ID
- LindaMcGrath201016316
- Status last verified
- May 2016
- First submitted
- 3 Apr 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualised Homeopathic Treatment on Low Sexual Desire in Perimenopause
- ClinicalTrials.gov ID
- NCT02419209
- Acronym / sponsor ID
- LindaMcGrath201016316
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- Low sexual desire, Perimenopause, Homeopathy, Hypoactive Sexual Desire Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Apr 2015 (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.
Low sexual desire, or decreased libido, is one of the most prevalent sexual complaints in females. Menopause is defined as the physiologic cessation of menses brought on by a decrease in ovarian function and is established once menses have been absent for at least twelve months. Perimenopause refers to the period shortly before as well as the twelve months after the last menstrual period. The duration of perimenopause varies greatly and signs and symptoms usually begin appearing during a woman's forties. A longitudinal study conducted in Seattle showed that women experienced a significant reduction in sexual desire during the late perimenopausal and early postmenopausal stages, with the biggest decline in sexual desire occurring from three years prior to two years after the final menstrual period. Despite being a prevalent female complaint, currently no standard treatment for low sexual desire exists. Homeopathy may offer a safe and effective solution for this common problem, however limited research has been conducted to date.
The aim of this study is to explore the effect of individualised homeopathic treatment on low sexual desire in perimenopausal females using detailed case studies, the desire and arousal subscales of the Female Sexual Function Index (FSFI) as well as Item 13 of the Female Sexual Distress Scale - Revised (FSDS-R).
Detailed description
This study is an embedded mixed method case study design and will take place at the University of Johannesburg Homeopathic Health Centre, Doornfontein Campus, over a period of twelve weeks. These twelve weeks will consist of four consultations per participant at four week intervals. Ten female participants aged 40-60 years who meet the inclusion criteria will be recruited by means of advertisements placed at the University of Johannesburg Doornfontein Campus as well as at pharmacies and health shops in the Gauteng area (with relevant permission given).
Once the volunteers agree to participate in the study, they will be requested to sign a Participant Information and Consent Form at the start of the initial consultation. Participants will also be requested to complete a screening questionnaire in order to determine whether they meet the inclusion and exclusion criteria. A complete case history will be taken for each participant who fits the inclusion criteria, using a detailed homeopathic case-taking form; vital signs will be checked and any necessary physical examinations will be performed. Participants will also complete the relevant Female Sexual Function Index (FSFI) subscales and Item 13 of the Female Sexual Distress Scale- Revised (FSDS-R).
The appropriate individualised homeopathic remedy for each participant will be selected using Mercurius Repertorisation Software Complete Repertory 2014 and the appropriate homeopathic Materia Medicas, under supervision of the attending clinician. At the follow-up consultations the case will be re-taken and the homeopathic medicine will either be repeated or changed based on the response of the participant to the medication previously administered following the principles of homeopathic prescribing. A relevant physical exam will be conducted, and participants will complete the relevant subscales of the FSFI and item 13 of the FSDS-R at each of the four consultations.
All data will be collected by the researcher during the course of the study. Qualitative data obtained from detailed case-takings will be used to write descriptive case studies. The FSFI subscales and FSDS-R Item 13 will be used to assess changes in desire and arousal across time and will be represented graphically. Due to the small sample size and qualitative nature of the cases no statistical analysis will be completed.
The outcome of this study may possibly indicate the effectiveness of individualised homeopathic treatment in low sexual desire associated with perimenopause. This study may provide the groundwork for future research on the effect of homeopathy on low sexual desire in females.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualised Homeopathic Remedy | Experimental | Other: Sucrose pillules medicated with the Individualised Homeopathic RemedyA single individualised homeopathic remedy will be administered to each participant in the form of medicated sucrose pillules. The potency, dosage and frequency of administration will be individualised for each participant in accordance with the laws that govern homeopathic prescribing. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females aged 40-60 years who are perimenopausal (up to one year after final menses)
- Low sexual desire present for the last 3 months
- At least 2 of the additional common signs and symptoms of perimenopause present for the last 3 months such as menorrhagia, irregular menses, amenorrhoea, hot flushes, night sweats, heart palpitations, insomnia, fatigue, mood swings, irritability, anxiety, memory and/or concentration loss, headaches, joint pain and vaginal dryness
- History of normal libido, with onset of low sexual desire coinciding with or appearing after the onset of other symptoms of perimenopause.
Key exclusion criteria (8 listed)
- Cessation of menses for more than 1 year (postmenopause)
- Total hysterectomy
- Early menopause (before age 40)
- Pelvic or abdominal surgery in the preceding 6 months
- Pregnant or lactating women or childbirth in the preceding 12 months
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 |
|---|---|---|
| Sucrose pillules medicated with the Individualised Homeopathic RemedySucrose pillules medicated with the Individualised Homeopathic Remedy and potency as selected by the researcher in accordance with the laws that govern individualised homeopathic prescribing. | Other | Individualised Homeopathic Remedy |
Primary outcome
Female Sexual Function Index
Time frame: Every fourth week for twelve weeks.
The Female Sexual Function Index (FSFI) covers six domains of female sexual function namely: desire, subjective arousal, lubrication, orgasm, satisfaction and pain. The study has shown a high test-retest reliability and a high degree of internal consistency for each of the six domains.
2 secondary outcomes
The Female Sexual Distress Scale (FSDS-R)
Time frame: Every fourth week for twelve weeks.
Individual participant case histories
Time frame: Every fourth week for twelve 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 May 2016.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
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.
Janice Pellow, M.TechHom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sucrose pillules medicated with the Individualised Homeopathic Remedy in people with Hypoactive Sexual Desire Disorder, run by University of Johannesburg at 1 site in South Africa.
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 May 2016. 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 South Africa. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: Every fourth week for twelve 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 May 2016.