ybrido(s) and SSRI's@home

• Conditions: Hypoactive Sexual Desire Disorder/SSRI-induced sexual dysfunction; MedDRA version: 14.1Level: HLTClassification code 10040470Term: Sexual desire disordersSystem Organ Class: 100000004873; MedDRA version: 14.1Level: LLTClassification code 10020933Term: Hypoactive sexual desire disorderSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2013-001966-40-NL
• Lead Sponsor: Companion Diagnostics BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-28
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Provision of written informed consent
2.Females between 18 and 70 years of age, inclusive, pre or postmenopausal, with HSDD or SSRI induced sexual dysfunction (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD]; only as secondary diagnosis) is allowed. The diagnosis of HSDD or SSRI induced sexual dysfunction will be established by a trained health care professional
3.Be involved in a stable, communicative, monogamous relationship and have a sexually functional partner who will be at home for the majority of the study duration
4.Healthy with normal medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
5.Use of highly effective contraception
6.For women who use SSRI: usage of an SSRI for the treatment of anxiety disorders or depression (not for, for example, anorexia nervosa or obsessive compulsive disorder) for a minimum of 3 months and on a stable dose for at least 6 weeks before screening. The following dosage ranges are allowed: Prozac (fluoxetine) 20-80 mg/day; fluvoxamine 100-300 mg/day; Zoloft (sertraline) 50-200 mg/day; Paxil (paroxetine) 20-60 mg/day; Celexa (citalopram) 20-40 mg/day; Lexapro (escitalopram) 10-30 mg/day

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 205
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
2.Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg (supine blood pressure). For subjects = 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 90 mmHg
3.Systolic blood pressure = 90 mmHg and/or diastolic blood pressure = 50 mmHg (supine blood pressure).
4.Use of any contraceptive containing anti-androgens or (anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
5.Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen
6.Pregnancy or intention to become pregnant during this study
7.Lactating or delivery in the previous 6 months prior to signing Informed Consent Form
8.History of bilateral oophorectomy
9.Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
10.Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms and/or FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms)
11.Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) < 60.00 mL/min based on the Cockcroft Gault formula)
12.Any current endocrine disease or endocrinopathy as determined by medical history, basic physical examination and/or laboratory values significantly outside normal range of the central laboratory; or uncontrolled diabetes mellitus(HbA1c > 7.5%)
13.Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: > 1.1 ng/dL, and total testosterone > 80 ng/dL)
14.Any current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results or which exclude from use of sildenafil, buspirone and/or testosterone
15.History of hormone dependent malignancy (including all types of breast cancer)
16.Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
17.History of serotonin syndrome
Psychological/Psychiatric Factors
18.History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered
19.(Psychotherapeutic and/or pharmacological treatment for) a psychiatric disorder (other than those under inclusion criterion 6) that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for sildenafil, buspirone and/or testosterone use
20.Current psychotherapeutic treatment for female sexual dysfunction
21.Current sexual disorder of vaginismus or dyspareunia according to the DSM IV TR, Anorgasmia with a lifelong inability to reach an orgasm
22.A 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
23.For women who use

Study & Design

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