Clinical Trials Register

Summary
EudraCT Number:	2009-016790-15
Sponsor's Protocol Code Number:	EB78
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2009-10-21
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2009-016790-15

A.3

Full title of the trial

A double blind, randomized, cross-over placebo controlled 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.

A.3.2

Name or abbreviated title of the trial where available

Lybrido(s) and SSRIs@Home

A.4.1

Sponsor's protocol code number

EB78

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Emotional Brain
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lybrido (formerly Libifem) and Lybridos
D.3.2	Product code	Lybrido and Lybridos
D.3.4	Pharmaceutical form	Capsule*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use Sublingual use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	testosterone
D.3.9.1	CAS number	58-22-0
D.3.9.2	Current sponsor code	testosteron sublingual
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sildenafil
D.3.9.1	CAS number	171599-83-0
D.3.9.2	Current sponsor code	sildenafil
D.3.9.3	Other descriptive name	viagra
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	buspirone
D.3.9.1	CAS number	36505-84-7
D.3.9.2	Current sponsor code	buspirone
D.3.9.3	Other descriptive name	buspar
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	administration of PDE5 inhibitor(sildenafil) in combination with sublingual testosterone and administration of a 5HT 1A receptor agonist (buspirone) in combination with sublingual testosteron

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule*
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed) and/or SSRI induced sexual dysfunctioning.

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate efficacy of Lybrido and Lybridos on subjective sexual experience in the domestic setting in healthy female subjects with Female Sexual Dysfunction using SSRIs.

E.2.2

Secondary objectives of the trial

- To evaluate efficacy of Lybrido and Lybridos on physiological sexual responding (vaginal and clitoral) in the domestic setting in different subgroups of women with FSD using SSRIs.
- To investigate differences in attentional bias for erotic stimuli in different subgroups of women with FSD using SSRIs, and the influence of Lybrido and Lybridos herein.
- To compare subjective, physiological and neuropsychological responding at home with the laboratory setting.
- To evaluate the safety of Lybrido and Lybridos in the domestic setting.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provision of written informed consent.
2. Female 21 – 70 years of age with Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed) and/or SSRI induced sexual dysfunctioning. 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.

E.4

Principal exclusion criteria

1 Use of oral contraception containing anti-androgens (Like Diane 35 or Minerva);
2 Use of oral contraception containing 50 μg estrogen or more;
3 Pregnancy, 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);
4 A pelvic inflammatory disease or an untreated vaginal infection at screening;
5 Lactating or subjects who have given birth in the previous 6 months;
6 Previous prolapse and incontinence surgery affecting the vaginal wall, which in the opinion of investigator would interfere with the VPA measurement;
7 Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns;
8 Childhood sexual abuse before the age of 16 (CSA as defined by the decision tree in Appendix 4);
9 PTSS as a result of sexual abuse (using the M.I.N.I plus 5.0.0 questionnaire)
10 History of endocrine disease;
11 History of severe neurological problems, current severe neurological problems, or other mild or moderate neurological problems which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the participant if she took part in the trial;
12 Treatment for a current serious psychiatric disorder (e.g., schizophrenia, psychosis ) or treatment for obsessive compulsive disorder, anorexia nervosa, bulimia nervosa and/or social anxiety neurosis.
13 Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity;
14 History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
15 Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 60-80 bpm in rest, > 90-115 bpm in moderate exercise), or other significant abnormality observed on ECG;
16 Systolic 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;
17 Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir;
18 Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine;
19 Acute/chronic liver disease: ASAT and ALAT > 3x the upper limit of normal;
20 Renal insufficiency (< 29 ml/min): based on the Cockcroft and Gault formula;
21 Use of medicinal herb as Ginkgo Biloba, St John's wort and nutrition containing grapefruit; avoid valerian, gotu kola, kava kava (may increase CNS depression)
22 Subjects who are taking nitrates or nitric oxide donors;
23 Subjects 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).
24 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; 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.
25 Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices;
26 Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires;
27 Any other clinically significant abnormality or condition which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if she took part in the trial;
28 Subjects who do not have easy access to a/their partner (for example because the partner works on a drilling platform at sea);
29 Subjects who are experiencing vision impairment, like partial or complete blindness or color blindness;
30 Subjects with a body mass index (BMI)>35 kg/m2;
31 Subjects who do not have easy access to the internet;
32 Subjects with a peri menopausal hormonal status
33 Clinical suspicion of carcinoid syndrome (spells of flushing, diaphoresis and abdominal cramps)
34 History of serotonin syndrome

E.5 End points

E.5.1

Primary end point(s)

Subjective ratings of sexual functioning (questionnaires & diary)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

last subject's end-of-study/follow up visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None, to date there is no treatment for female sexual dysfunction

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-10-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-12-03

P. End of Trial
P.	End of Trial Status	Ongoing

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