Hypoactive Sexual Desire DisorderNCT00916396
Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder
A study testing Dehydroepiandrosterone in people with Hypoactive Sexual Desire Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Hypoactive Sexual Desire Disorder (HSDD) is a common syndrome characterized by low sexual desire causing marked distress. The involvement of DHEA in sexual function is unknown, however, DHEA treatment increased desire in depressed subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Dehydroepiandrosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2005to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman participating in the research will be in the menopausal phase or after it (above a year in postmenopause)aged 65 and below. Man age range will be 18 - 65.
Who cannot join
- Individuals suffering from a significant systemic illness, hormonal illness, alcoholism, drug abuse, major depression, "Mano/matroagia" or hypogonadism. Additionally, individuals treated with androgens, antidepressant or any other medication which may cause a disorder in sexual desire.
- Man diagnosed as suffering from prostate carcinoma, BHP or will show PSA levels above 2.5 will not be included.
- Woman treated with HRT or suffering from any of the following diseases will not be included: breast carcinoma, ovarian or uterus cancer or with a first grade family history of one of the mentioned.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Aviv Medical Center
Tel Aviv
Miki Bloch, MD, 972-3-6974707, mikib@tasmc.health.gov.il
About this study
Official title: Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder: Modulation of Sexual Libido by Androgens and Neurosteroids
Hypoactive Sexual Desire Disorder (HSDD) is a common syndrome characterized by low sexual desire causing marked distress. The involvement of DHEA in sexual function is unknown, however, DHEA treatment increased desire in depressed subjects. In the current research, we will treat 45 women and men suffering from low sexual desire with DHEA or placebo for 6 weeks. The study's primary goal is to determine the effect of DHEA treatment on sexual desire, and to find if there is a connection between levels of hormones and change in desire. Outcome measures will include hormonal levels and psychological state. Our secondary goal is to compare baseline hormones measures in individuals with low sexual desire to normal controls. For that purpose we will measure the hormonal baseline levels among 20 normal subjects.
Read the detailed description
Hypoactive Sexual Desire Disorder (HSDD) is a very common syndrome in adult women and men, characterized by a severe deficiency in the desire for sexual activity, causing marked distress. There is some data that androgens such as testosterone have some beneficial effect in this condition. DHEA is a neurosteroid that is metabolized into testosterone and estrogen, both of assumed importance in the regulation of sexual libido. The direct involvement of DHEA in the regulation of sexual function is unknown, however, DHEA treatment improved libido in midlife-onset depressed subjects. In this study, we will treat women and men suffering from HSDD with DHEA. The study's first objective is to determine the effect of DHEA treatment on sexual libido in menopausal women and both young and mid-aged men. The secondary objective is to compare baseline measures of DHEA, androgens, and other neurosteroids, in individuals with HSDD to controls. Furthermore, we will investigate possible correlations between plasma and urine levels of several neurosteroids and change in measures of libido. Fifty women and men diagnosed with HSDD will be treated with either 100 mg of DHEA or placebo for 6 weeks, in a double-blind, placebo-controlled study. Outcome measures will include several 17-Ketosteroids, DHEAS and bioavailable testosterone. Psychological outcome measures will include sexual function, mood and well-being. Twenty controls without HSDD will also be recruited to determine and compare their baseline levels of neurosteroids.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Dehydroepiandrosterone, placebo
- 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.
DehydroepiandrosteroneDrug
Also called DHEA
100 mg of DHEA a day (50 mg twice a day) for six weeks
placeboDrug
100 mg of Placebo a day (50 mg twice a day) for six weeks
| Study group | Role | What they receive |
|---|---|---|
| real drug | Active comparator | Not described Receives: Drug: Dehydroepiandrosterone |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood and urine tests
Measured: beginning of treatment, and after six weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2005
- Primary completionJan 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Miki Bloch, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916396
- Sponsor's protocol ID
- tasmc-09-MB-158-ctil
- Status last verified
- Nov 2009
- First submitted
- 7 Jun 2009
- Last updated
- 1 Dec 2009
- Results posted
- No
Publications
Bloch M, Meiboom H, Zaig I, Schreiber S, Abramov L. The use of dehydroepiandrosterone in the treatment of hypoactive sexual desire disorder: a report of gender differences. Eur Neuropsychopharmacol. 2013 Aug;23(8):910-8. doi: 10.1016/j.euroneuro.2012.09.004. Epub 2012 Oct 18.
PubMed 23084789
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder: Modulation of Sexual Libido by Androgens and Neurosteroids
- ClinicalTrials.gov ID
- NCT00916396
- Acronym / sponsor ID
- tasmc-09-MB-158-ctil
- Conditions
- Hypoactive Sexual Desire Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2005
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Jun 2009 (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.
Hypoactive Sexual Desire Disorder (HSDD) is a common syndrome characterized by low sexual desire causing marked distress. The involvement of DHEA in sexual function is unknown, however, DHEA treatment increased desire in depressed subjects. In the current research, we will treat 45 women and men suffering from low sexual desire with DHEA or placebo for 6 weeks. The study's primary goal is to determine the effect of DHEA treatment on sexual desire, and to find if there is a connection between levels of hormones and change in desire. Outcome measures will include hormonal levels and psychological state. Our secondary goal is to compare baseline hormones measures in individuals with low sexual desire to normal controls. For that purpose we will measure the hormonal baseline levels among 20 normal subjects.
Detailed description
Hypoactive Sexual Desire Disorder (HSDD) is a very common syndrome in adult women and men, characterized by a severe deficiency in the desire for sexual activity, causing marked distress. There is some data that androgens such as testosterone have some beneficial effect in this condition. DHEA is a neurosteroid that is metabolized into testosterone and estrogen, both of assumed importance in the regulation of sexual libido. The direct involvement of DHEA in the regulation of sexual function is unknown, however, DHEA treatment improved libido in midlife-onset depressed subjects. In this study, we will treat women and men suffering from HSDD with DHEA. The study's first objective is to determine the effect of DHEA treatment on sexual libido in menopausal women and both young and mid-aged men. The secondary objective is to compare baseline measures of DHEA, androgens, and other neurosteroids, in individuals with HSDD to controls. Furthermore, we will investigate possible correlations between plasma and urine levels of several neurosteroids and change in measures of libido. Fifty women and men diagnosed with HSDD will be treated with either 100 mg of DHEA or placebo for 6 weeks, in a double-blind, placebo-controlled study. Outcome measures will include several 17-Ketosteroids, DHEAS and bioavailable testosterone. Psychological outcome measures will include sexual function, mood and well-being. Twenty controls without HSDD will also be recruited to determine and compare their baseline levels of neurosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real drug | Active comparator | Drug: Dehydroepiandrosterone |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Woman participating in the research will be in the menopausal phase or after it (above a year in postmenopause)aged 65 and below. Man age range will be 18 - 65.
Key exclusion criteria (3 listed)
- Individuals suffering from a significant systemic illness, hormonal illness, alcoholism, drug abuse, major depression, "Mano/matroagia" or hypogonadism. Additionally, individuals treated with androgens, antidepressant or any other medication which may cause a disorder in sexual desire.
- Man diagnosed as suffering from prostate carcinoma, BHP or will show PSA levels above 2.5 will not be included.
- Woman treated with HRT or suffering from any of the following diseases will not be included: breast carcinoma, ovarian or uterus cancer or with a first grade family history of one of the mentioned.
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 |
|---|---|---|
| DehydroepiandrosteroneAlso: DHEA100 mg of DHEA a day (50 mg twice a day) for six weeks | Drug | real drug |
| placebo100 mg of Placebo a day (50 mg twice a day) for six weeks | Drug | placebo |
Primary outcome
blood and urine tests
Time frame: beginning of treatment, and after six weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
- Derived from this study: PubMed 23084789Bloch M, Meiboom H, Zaig I, Schreiber S, Abramov L. The use of dehydroepiandrosterone in the treatment of hypoactive sexual desire disorder: a report of gender differences. Eur Neuropsychopharmacol. 2013 Aug;23(8):910-8. doi: 10.1016/j.euroneuro.2012.09.004. Epub 2012 Oct 18.
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.
Miki Bloch, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydroepiandrosterone in people with Hypoactive Sexual Desire Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Dec 2009. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood and urine tests (time frame: beginning of treatment, and after six weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916396, which also lists 1 linked publication.
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 1 Dec 2009.