Clinical Trials Register

Summary
EudraCT Number:	2011-001310-34
Sponsor's Protocol Code Number:	OXY-COUP-PROT1.4
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-07-22
Trial results	View 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

Austria - BASG

A.2

EudraCT number

2011-001310-34

A.3

Full title of the trial

Female Sexual Dysfunction in the Peri and Postmenopause: Effect of intranasal Oxytocin administration on sexual function and activity

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Intranasal Oxytocin administration on sexual function and activity

A.3.2

Name or abbreviated title of the trial where available

OXY-COUP-PROT1.4

A.4.1

Sponsor's protocol code number

OXY-COUP-PROT1.4

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Med. Univ. Wien, Univ. Klinik für Innere Med. III
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Med. Univ. Wien, Innere III
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Med. Univ. Wien
B.5.2	Functional name of contact point	Prof. M. Bayerle-Eder
B.5.3	Address:
B.5.3.1	Street Address	Währinger Gürtel 18-20
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	00431404004310
B.5.5	Fax number	0043140593234
B.5.6	E-mail	michaela.bayerle-eder@meduniwien.ac.at

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	Yes
D.2.1.1.1	Trade name	Syntocinon spray
D.2.1.1.2	Name of the Marketing Authorisation holder	Defiante Pharmaceutics
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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.3.4	Pharmaceutical form	Nasal spray, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intranasal use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	50-56-6
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	40 I.E/ ml
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	No

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	Nasal spray, solution
D.8.4	Route of administration of the placebo	Nasal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Sexual behaviour with reduced intercourse frequency due to female sexual function disorders

E.1.1.1

Medical condition in easily understood language

sexual behaviour with rare intercourse due to female sexual function disorders

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

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 the effect of intranasal Oxytocin administration on female sexuality

E.2.2

Secondary objectives of the trial

• Female Sexual Distress Scale (FSDS)
• International Index of Erectile Function (IIEF-5)
• Partner Performance Questionnaire (PPQ)
• Maximum urinary flow (men)
• Oxytocin, Prolactine, Progesterone, Estradiol,
• FSH, early morning Cortisol, LH, Vasopressin, free Testosterone, total testosterone, SHBG, DHEA
• Blood pressure and blood osmolarity (women)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Females with hypoactive sexual desire, arousal or orgasmic
disorders as assed by FSFI <27
• Willingness to perfrom a pregnancy test every month for premenopausal women
Willingness to use contraception during the study period for premenopausal women

• Ongoing sexual active relationship for at least 3 months
• Female subjects must be older tha 40 years
• Male subjects must be older than 18
• Normal findings in the urogenital tract unless the investigator
considers an abnormality to be clinically irrelevant
• Normal laboratory values unless the investigator considers an
abnormality to be clinically irrelevant
• Normal findings in the medical history and physical
examination unless the investigator considers an abnormality
to be clinically irrelevant
• Willingness to attempt sexual intercourse and/ or masturbation
at least two times per week

E.4

Principal exclusion criteria

• Abuse of alcoholic beverages or drugs, participation in a
clinical trial during 3 weeks preceding the study
• Symptoms of a clinically relevant illness during 3 weeks
before the first study day
• Presence of hepatic or renal dysfunction
• Patients with known hypersensitivity to the study drug or any
ingredients
• Blood or plasma donation during the previous 3 weeks
• Any sexual pain conditions
• Smoking > 10 cigarettes a day
• BMI < 18 and > 35 kg/m2

Exclusion Criteria
For females
Pregnancy
• Lifelong, but not acquired, hypoactive sexual disorder
• Chronic sinusitis or recurrent Ear-Nose-Throat infections
• History or presence of cardiovascular disease and untreated
hypertension
• Pelvic or genital diseases
• Recurrent infections of the urogenital tract
• Female genital prolapsed
• History of hysterotomy
• Presence of a major depression or any psychiatric disease
• History of sexual abuse or primary sexual dysfunction

Exclusion Criteria
for males (n=5) with
erectile dysfunction
receiving a PDE 5
inhibitor
• clinically significant renal insufficiency
• clinically significant hepatobiliary disease
• Hemoglobin A1c >13% at Visit 1.
• chronic stable angina treated with long-acting nitrates, or
with chronic stable angina requiring short-acting nitrates in the last
90 days, or with angina occurring during sexual intercourse in the
last 6 months.
• unstable angina 6 months before Visit 1
• history of myocardial infarction or coronary artery bypass graft
surgery within 90 days before Visit 1 or percutaneous coronary
intervention (for example, angioplasty or stent placement) within
90 days before Visit 1.
• supraventricular arrhythmia with an uncontrolled ventricular
response (mean heart rate >100 bpm) at rest, or have any history of
spontaneous or induced sustained ventricular tachycardia (heart
rate >100 bpm for !30 sec), or use an automatic internal
cardioverterdefibrillator.
• history of sudden cardiac arrest.
evidence of congestive heart failure (NYHA Class 2 or
above) within 6 months before Visit 1.
• new, significant cardiac conduction defect within 90 days before
Visit 1.
• systolic blood pressure >170 or <90 mm Hg or diastolic blood
pressure >100 or <50 mm Hg at screening (if stress is suspected,
retest under basal conditions), or have history of malignant
hypertension.
• history of significant central nervous system injuries (including
stroke or spinal cord injury) within the last 6 months.
• history of Human Immunodeficiency Virus (HIV) infection.
• inability to provide informed consent or uncompliance
• current treatment with nitrates, cancer chemotherapy, or
antiandrogens [except finasteride taken as Proscar2, or Avodart2!
(dutasteride)]
• history of drug, alcohol, or substance abuse within the past 6
months

E.5 End points

E.5.1

Primary end point(s)

Female Sexual Function Index (FSFI) total score
Sexual Activity Record (SAR)

E.5.1.1

Timepoint(s) of evaluation of this end point

FSFI: week 1, 5, 8, 12, 18, 22
SAR: week 5, 8, 12, 18, 22

E.5.2

Secondary end point(s)

Female Sexual Distress Scale (FSDS)
• International Index of Erectile Function (IIEF-5)
• Partner Performance Questionnaire (PPQ)
• Sexual life quality questionnaire (SLQQ)
• Maximum urinary flow (men)
• Oxytocin, Dopamine, Prolactine, Progesterone,
Estradiol,
• FSH, early morning Cortisol, LH, Vasopressin, free
Testosterone, total testosterone, SHBG, DHEA
• Blood pressure and blood osmolarity (women)
Primary Endpoint Improvement of the FSFI total score and SAR score by 5 %
Evaluation of safety
and
efficiency parameters
Adverse reactions will be assessed by collecting the patients
diary every 2 to 4 weeks, before the 1st study day females
will be trained to use the Syntocinon® Spray and will stay
at the ward for 1 hour to asses possible adverse reactions
FSFI, SAR, SLQQ, IIEF, PPQ questionnaires will be
distributed and collected every 4 to 8 weeks

E.5.2.1

Timepoint(s) of evaluation of this end point

week 1, 5, 8, 12, 18, 22, 26

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

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

E.6.8

Bioequivalence

E.6.9

Dose response

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

Yes

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.8.2.4

Number of treatment arms in the trial

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.8.5

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

E.8.7

Trial has a data monitoring committee

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

LVLS

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.1.2.1

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

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

2011-08-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-11-25

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