Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00034021
• Date of registration: 19/04/2002
• Primary sponsor: National Center for Complementary and Alternative Medicine (NCCAM)
• Public title: Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
• Scientific title: Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
• Date of first enrolment: June 2002
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00034021
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Cindy Meston, PhD
• Affiliation: University of Texas at Austin

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria

- 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.

- 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:

1. Anticoagulant medications (e.g., warfarin, heparin).

2. Chronic, daily use of dehydroepiandrosterone (DHEA), testosterone and other
androgens, estrogen (in hormone replacement therapy), tamoxifen, raloxifene, and
other SERMs.

3. Nitrates.

4. Any current use of GBE.

5. Chemotherapy agents.

6. Antipsychotic, antianxiety, or sedative/hypnotic agents.

7. Antidepressants other than fluoxetine, sertraline, or paroxetine.

8. 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).

9. Any approved or experimental medications or treatments used to enhance the
sexual response.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hypoactive Sexual Desire Disorder

Sexual Dysfunctions, Psychological

Intervention(s)

Behavioral: Sex Therapy (genital focus)

Drug: Ginkgo Biloba

Secondary ID(s)

R01 AT000224-01A2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors