A double blind, randomized, placebo controlled cross-over study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female subjects with Female Sexual Dysfunction in combination with SSRI use. - Lybrido(s) and SSRIs@Home

• Conditions: Hypoactive sexual desire disorder and female sexual arousal disorder in combination with SSRI use.

• Registration Number: EUCTR2008-002735-32-NL
• Lead Sponsor: Emotional Brain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Provision of written informed consent.
2.Female 21 – 70 years of age with Hypoactive Sexual Desire Disorder and/or Female Sexual Arousal Disorder and/or SSRI induced sexual disfunctioning; subjects must have experienced low sexual arousal and / or low sexual desire for at least one month prior to study entry according to DSM IV criteria. The diagnosis will be made by an experienced psychologist/sexologist.
3.Usage of a SSRI for at least 3 months.
4.The SSRI must be on a stable dose for at least 6 weeks.
5.Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically irrelevant.
6.Subjects must have a heterosexual relationship.
7.Subjects must have developed FSD before using SSRIs or developed FSD during the usage of a SSRI.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1Use of oral contraception containing anti-androgens (Like Diane 35 or Minerva);
2Use of oral contraception containing 50 µg estrogen or more;
3Pregnancy, or intention to become pregnant during this study (Note: a serum or urine pregnancy test will be performed in all women prior to the administration of study medications);
4A pelvic inflammatory disease or an untreated vaginal infection at screening;
5Lactating or subjects who have given birth in the previous 6 months;
6Previous prolapse and incontinence surgery affecting the vaginal wall;
7Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns;
8History of endocrinological treatment or current endocrinological treatment (with the exception of the use oral contraceptives and of fertility-promoting treatment);
9History of neurological treatment or current neurological treatment;
10History of serious psychiatric treatment (e.g.,schizophrenia, psychosis) or current treatment for psychiatric disorders like obsessive compulsive disorder, and anorexia nervosa.
11Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity;
12History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
13Uncontrolled atr ial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG;
14Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg. For subjects with age > 60 years and without diabetic mellitus, familiar hypercholesterolemia or cardiovascular disease: Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg (According to the CBO-guideline hypertension (CBO.2000a)). Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg.
15Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol
16Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir
17Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine
18Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;
19Use of medicinal herb as Ginkgo Biloba, St John's wort and nutrition containing grapefruit; avoid valerian, gotu kola, kava kava (may increase CNS depression)
20Subjects who are taking nitrates or nitric oxide donors;
21Subjects who are taking MAO inhibitors (includes classic MAO inhibitors and linezolid), Calcium channel blockers (e.g. Diltiazem and verapamil), Nefazodone, Trazodon, TCAs, tramadol, any medicine belonging to the triptans (i.e. sumatriptan).
22A substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study; mild or moderately alcohol drinking behavior is allowed, only 12 hours before the experimental days is alcohol drinking not allowed. Three weeks before the start of the experimental day is the taking of any recreational drug not allowed. Smoking is allowed.
23Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices;
24Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires;
25Any other clinically signifi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified