Hypoactive Sexual Desire DisorderPhase 2NCT00034021
Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
A Phase 2 study testing Ginkgo Biloba and Sex Therapy (genital focus) in people with Hypoactive Sexual Desire Disorder and Sexual Dysfunctions, Psychological, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to provide the first empirical examination of the effects of Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and physiological measures of sexual function in women who are experiencing sexual disorders secondary to antidepressants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder, Sexual Dysfunctions, Psychological
- What is being tested?
- Ginkgo Biloba and Sex Therapy (genital focus)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Sep 2004
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proficient in English
- Patients must be currently involved in a heterosexual relationship in which they are willing to engage in at least two sexual encounters (with intent to attain orgasm) per week during the course of the study;
- Patients who report an onset of Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, or Female Orgasmic Disorder no less than one week and no more than 3 months after beginning treatment with either fluoxetine, sertraline, or paroxetine;
- Patients who have been receiving treatment with either fluoxetine, sertraline, or paroxetine for a minimum of 10 weeks (and are currently receiving fluoxetine, sertraline, or paroxetine treatment);
- Subjects must describe the sexual dysfunction as following the otherwise successful treatment with the antidepressant, and as being distinctly different from any sexual dysfunction they may have noticed prior to starting antidepressant treatment.
- Patients must agree to not use aspirin during the course of the study, and agree to use a medically accepted form of birth control for the duration of the study.
- Patients must agree to not supplement their diet with GBE throughout the duration of the study (outside of that which they receive as part of the study medication).
- Patient must live in Austin Texas
Who cannot join
- Under the age of 18 or over the age of 65
- Subjects with amenorrhea for > 6 months.
- Women who are pregnant (as determined by a pregnancy test) or are intending to become pregnant during the course of the study, and subjects who are lactating or are <1 year post-partum.
- Patients with a history of bleeding disorders.
- History of HIV infection or active, untreated pelvic or urinary tract infection including, sexually transmitted diseases such as chlamydia, genital herpes, gonorrhea, or syphilis.
- Major pelvic surgery that may have caused nerve damage, including: vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery.
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- Neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
- Clinically significant untreated renal or endocrine disease. Uncontrolled hypotension or hypertension manifested by systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg (if stress is suspected, participants will be retested under basal conditions).
- Patients with any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for >30 sec) despite medical or device therapy, or the presence of an automatic internal cardioverter defibrillator.
- A history of sudden cardiac arrest despite medical or device therapy, or any evidence of congestive heart failure within 6 months prior to the first visit.
- Hamilton Depression Rating Scale (HAM-D) score greater than or equal to 15.
- History of drug, alcohol, or substance abuse within the past 6 months.
- Evidence of an untreated Axis I psychiatric disorder, including schizophrenia, manic-depressive disorder, delusional disorder, or psychotic disorders not classified elsewhere.
- Patients who are not currently involved in a heterosexual relationship in which they are willing to engage in at least two sexual encounters per week.
- Subjects with a history of sexual trauma (defined as serious distress caused by unwanted or coercive sexual activity), including sexual abuse, molestation, rape, and sexual phobias.
- Patients who report experiencing clinically significant sexual difficulties, including hypoactive sexual desire disorder, sexual arousal disorder, or inhibited orgasm prior to antidepressant treatment, or who report an onset of sexual dysfunction less than one week or more than 3 months after beginning antidepressant treatment.
- Patients with Vaginismus, Sexual Aversion Disorder, or Dyspareunia (unless the Dyspareunia is secondary to Female Sexual Arousal Disorder and is reversed with the use of a sexual lubricant).
- Patients who are currently receiving psychological intervention that specifically focuses on sexuality issues.
- Patients who pose a current, serious suicidal or homicidal risk.
- Any other condition, which in the opinion of the investigator, would put the participant at risk and warrant precluding from the study.
- Patients receiving any of the following medications will be precluded from the study. If any of the medications listed below become necessary during the course of the study, the participant will be discontinued from the study:
- Anticoagulant medications (e.g., warfarin, heparin).
- Chronic, daily use of dehydroepiandrosterone (DHEA), testosterone and other androgens, estrogen (in hormone replacement therapy), tamoxifen, raloxifene, and other SERMs.
- Nitrates.
- Any current use of GBE.
- Chemotherapy agents.
- Antipsychotic, antianxiety, or sedative/hypnotic agents.
- Antidepressants other than fluoxetine, sertraline, or paroxetine.
- Agents that may affect the sexual response including cyprotrone acetate, antihistamines, decongestants containing pseudoephedrine or ephedrine, beta adrenergic blocking agents (beta blockers), clonidine, or sildenafil (Viagra).
- Any approved or experimental medications or treatments used to enhance the sexual response.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to provide the first empirical examination of the effects of Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and physiological measures of sexual function in women who are experiencing sexual disorders secondary to antidepressants.
Read the detailed description
Virtually all antidepressant medications are associated with a high incidence of adverse sexual side effects. In women, the side effects most commonly reported include decreased sexual arousal with decreased lubrication, delayed or inhibited orgasm, and decreased sexual desire. To date, there are no effective pharmacological antidotes for treating these sexual side effects. Ginkgo biloba extract (GBE), a naturally occurring substance from the ancient Chinese Ginkgo tree, has properties proven to increase peripheral blood flow and to facilitate the relaxation of smooth muscle tissue. Its effectiveness in this regard has been demonstrated in numerous clinical trials that show gingko biloba to be highly efficient in treating peripheral vascular disorders. Female sexual arousal involves a complex interplay of these very actions - the relaxation of smooth muscle tissue and the inflow of blood to the genital region. Hence, pharmacologically, it is feasible that GBE may be effective in enhancing female sexual arousal. Moreover, given that the mechanisms hypothesized to facilitate female sexual function are operative at a peripheral rather than a central (i.e., neurotransmitter) level, it is unlikely that GBE would adversely impact the mood-alleviating therapeutic effects of antidepressant medications that are believed to be centrally mediated. Limited, uncontrolled studies lend support to this hypothesis. The purpose of the present study is to provide the first empirical examination of the effects of both acute and chronic GBE on subjective and physiological measures of sexual function in women who are experiencing clinically diagnosable hypoactive sexual desire disorder, female sexual arousal disorder, and/or inhibited female orgasm secondary to either to fluoxetine, sertraline, or paroxetine use. Women (N = 110) stabilized on antidepressant medication and free of a current Axis I disorder will be randomized to 8 weeks of daily treatment with either GBE (200 mg) or placebo. Sexual functioning will be assessed through (a) daily patient diary recordings, (b) patient-rating scales completed each week, and (c) blind independent evaluator ratings. The acute effects of GBE will also be assessed using vaginal photoplethysmograph techniques to assess genital blood flow, both prior to and following chronic GBE treatment. The findings from the present study will (a) help determine whether chronic and/or acute GBE facilitates sexual function in women with antidepressant-induced sexual dysfunction and, (b) examine whether acute GBE influences vaginal measures of sexual arousal. If effective, GBE could play a significant adjunctive role in the treatment of clinical depression and other psychological disorders commonly treated with antidepressant medications.
- Being tested
- Ginkgo Biloba, Sex Therapy (genital focus)
- Keywords
- Female Sexual Arousal Disorder, Female Orgasmic Disorder, ginkgo biloba, human therapy evaluation, sex behavior, antidepressant, blood flow, clinical trial, drug adverse effect, mental disorder chemotherapy, relaxation, smooth muscle, alternative medicine, blood flow measurement, female, placebo, women's health, Secondary to either to fluoxetine, sertraline, or paroxetine use.
- Medical subject headings
- Sexual Dysfunctions, Psychological, Sexual Behavior, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo BilobaDrug
Sex Therapy (genital focus)Behavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2002 (estimated)
- Study startJun 2002
- Study completionSep 2004
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Cindy Meston, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034021
- Sponsor's protocol ID
- R01AT000224-01A2
- Status last verified
- Jul 2006
- First submitted
- 19 Apr 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT00034021
- Acronym / sponsor ID
- R01AT000224-01A2
- Keywords
- Female Sexual Arousal Disorder, Female Orgasmic Disorder, ginkgo biloba, human therapy evaluation, sex behavior, antidepressant, blood flow, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jun 2002
- Study completion
- Sep 2004
- First posted
- 22 Apr 2002 (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.
The purpose of this study is to provide the first empirical examination of the effects of Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and physiological measures of sexual function in women who are experiencing sexual disorders secondary to antidepressants.
Detailed description
Virtually all antidepressant medications are associated with a high incidence of adverse sexual side effects. In women, the side effects most commonly reported include decreased sexual arousal with decreased lubrication, delayed or inhibited orgasm, and decreased sexual desire. To date, there are no effective pharmacological antidotes for treating these sexual side effects. Ginkgo biloba extract (GBE), a naturally occurring substance from the ancient Chinese Ginkgo tree, has properties proven to increase peripheral blood flow and to facilitate the relaxation of smooth muscle tissue. Its effectiveness in this regard has been demonstrated in numerous clinical trials that show gingko biloba to be highly efficient in treating peripheral vascular disorders. Female sexual arousal involves a complex interplay of these very actions - the relaxation of smooth muscle tissue and the inflow of blood to the genital region. Hence, pharmacologically, it is feasible that GBE may be effective in enhancing female sexual arousal. Moreover, given that the mechanisms hypothesized to facilitate female sexual function are operative at a peripheral rather than a central (i.e., neurotransmitter) level, it is unlikely that GBE would adversely impact the mood-alleviating therapeutic effects of antidepressant medications that are believed to be centrally mediated. Limited, uncontrolled studies lend support to this hypothesis. The purpose of the present study is to provide the first empirical examination of the effects of both acute and chronic GBE on subjective and physiological measures of sexual function in women who are experiencing clinically diagnosable hypoactive sexual desire disorder, female sexual arousal disorder, and/or inhibited female orgasm secondary to either to fluoxetine, sertraline, or paroxetine use. Women (N = 110) stabilized on antidepressant medication and free of a current Axis I disorder will be randomized to 8 weeks of daily treatment with either GBE (200 mg) or placebo. Sexual functioning will be assessed through (a) daily patient diary recordings, (b) patient-rating scales completed each week, and (c) blind independent evaluator ratings. The acute effects of GBE will also be assessed using vaginal photoplethysmograph techniques to assess genital blood flow, both prior to and following chronic GBE treatment. The findings from the present study will (a) help determine whether chronic and/or acute GBE facilitates sexual function in women with antidepressant-induced sexual dysfunction and, (b) examine whether acute GBE influences vaginal measures of sexual arousal. If effective, GBE could play a significant adjunctive role in the treatment of clinical depression and other psychological disorders commonly treated with antidepressant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Proficient in English
- Patients must be currently involved in a heterosexual relationship in which they are willing to engage in at least two sexual encounters (with intent to attain orgasm) per week during the course of the study;
- Patients who report an onset of Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, or Female Orgasmic Disorder no less than one week and no more than 3 months after beginning treatment with either fluoxetine, sertraline, or paroxetine;
- Patients who have been receiving treatment with either fluoxetine, sertraline, or paroxetine for a minimum of 10 weeks (and are currently receiving fluoxetine, sertraline, or paroxetine treatment);
- Subjects must describe the sexual dysfunction as following the otherwise successful treatment with the antidepressant, and as being distinctly different from any sexual dysfunction they may have noticed prior to starting antidepressant treatment.
Key exclusion criteria (30 listed)
- Under the age of 18 or over the age of 65
- Subjects with amenorrhea for > 6 months.
- Women who are pregnant (as determined by a pregnancy test) or are intending to become pregnant during the course of the study, and subjects who are lactating or are <1 year post-partum.
- Patients with a history of bleeding disorders.
- History of HIV infection or active, untreated pelvic or urinary tract infection including, sexually transmitted diseases such as chlamydia, genital herpes, gonorrhea, or syphilis.
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 |
|---|---|---|
| Ginkgo Biloba | Drug | – |
| Sex Therapy (genital focus) | Behavioural | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2006.
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.
Cindy Meston, PhD principal investigator
University of Texas at Austin
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 Ginkgo Biloba and Sex Therapy (genital focus) in people with Hypoactive Sexual Desire Disorder and Sexual Dysfunctions, Psychological, run by National Center for Complementary and Integrative Health (NCCIH) 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 8 inclusion and 30 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 18 Aug 2006. 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.
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.
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 18 Aug 2006.