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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01607658




Registration number
NCT01607658
Ethics application status
Date submitted
18/05/2012
Date registered
30/05/2012
Date last updated
13/08/2018

Titles & IDs
Public title
Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
Scientific title
A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Efficacy and Safety of TBS-2 Intranasal Testosterone Gel in Women With Acquired Female Orgasmic Disorder
Secondary ID [1] 0 0
TBS-2-AMB-2012-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Orgasmic Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Low dose TBS-2
Treatment: Drugs - Medium dose TBS-2
Treatment: Drugs - High dose TBS-2

Placebo comparator: Placebo - Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event

Experimental: Experimental 1 - Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn

Experimental: Experimental 2 - Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn

Experimental: Experimental 3 - High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn


Treatment: Drugs: Placebo
placebo intranasal gel administered prn, 2-8 hours before a planned sexual event

Treatment: Drugs: Low dose TBS-2
Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Treatment: Drugs: Medium dose TBS-2
Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Treatment: Drugs: High dose TBS-2
High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
Timepoint [1] 0 0
84 days
Secondary outcome [1] 0 0
Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)
Timepoint [1] 0 0
Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)
Secondary outcome [2] 0 0
Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84
Timepoint [2] 0 0
Day 0 and Day 84
Secondary outcome [3] 0 0
Change in Global Sexual Functioning From Day 0 to Day 84
Timepoint [3] 0 0
Day 0 and Day 84

Eligibility
Key inclusion criteria
Inclusion Criteria

Subjects who meet the following criteria may be included in the study:

At Visit 1:=

* Be a generally healthy female aged 18 years and older, inclusive, who has no physical impediment to sexual function
* Have a diagnosis of acquired female orgasmic disorder defined as absence of orgasm during the past 6 months and according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria. Subtype should be generalized and not due to etiological factors that would be unlikely to be related to hormone function (eg, depression, relationship discord, alcoholism, surgery, injury). Hypoactive sexual desire disorder as a co-morbid disorder is allowed only if it began after the female orgasmic disorder diagnosis;
* Have a score of >15 with a score of =2 for question #15 on the FSDS DAO at Screening Visit;
* Be a sexually active, hetero- or homosexual woman in a steady relationship for at least 6 months and agree to have at least 4 sexual events over 28-day period of time. The subject's partner should not have any untreated sexual dysfunctions;
* Be on a reliable birth control method (ie, stable systemic hormonal contraception for the whole duration of the study and 30 days after study completion [for at least 3 months prior to study], IUD, barrier method) or not engaging in heterosexual intercourse. Birth control method used by subject at screening is not to be changed during the course of the study;
* Have a normal ENT examination;
* Have a body mass index =35;
* Have a clinically acceptable pelvic examination and Pap smear as read by a licensed laboratory facility (no evidence of malignancy) within the 2 years prior to Randomization;
* Have a clinically acceptable mammogram;
* Be able to complete a web-based questionnaire within 24 hours of each sexual event;
* Be able to read English and provide written informed consent; and

At Visit 2:

* Have at least 4 sexual events and an absence of orgasm during the 28 day Screening/Baseline Period as determined by MONASH WHP FSSQ.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Subjects who meet any of the following criteria will not be eligible to participate in the study:

* Have a known history of hypersensitivity to testosterone or any component of the study drug;
* Have a history of any clinically relevant psychiatric disorder that could impact sexual functioning, contribute to increased risk for patient safety, or significantly compromise participation in the study (eg, bipolar disorders, psychotic disorders, severe anxiety, eating disorders, borderline personality disorder, untreated Major Depressive Disorder);
* Have a score of =14 on the Beck Depression Inventory II at Screening Visit. Subjects with a score of =14 and =19 at Screening may be eligible to participate in the study if a specialist (psychologist or psychiatrist) concludes that the subject is not clinically depressed;
* Have other concurrent female sexual dysfunction disorders as defined by DSM-IV criteria, eg, Sexual Aversion Disorder, Substance-Induced sexual dysfunction, dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), vaginismus, Gender Identity Disorder, paraphilia, or sexual dysfunction due to a general medical condition;
* Be experiencing relational discord;
* Have a history of dementia or other neurodegenerative diseases, organic brain disease, stroke, transient ischemic attacks, brain surgery, significant brain trauma, multiple sclerosis, spinal cord injury, peripheral neuropathy, and epilepsy (febrile seizures limited to childhood do not exclude patients);
* Be currently receiving treatment with selective norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) and/or medications that interfere with the metabolism of testosterone (eg, anastrozole, clomiphene, testolactone, ketoconazole, spironolactone, histamine 2 [H2 receptor blockers, etc.]);
* Have a history of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or be a regular drinker of more than 3 units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit);
* Have a history of cancer other than nonmelanotic skin cancer;
* Have a history of deep venous thrombosis or coagulation disorders;
* Have a significant medical condition (eg, hepatic, renal cardiovascular, endocrine including diabetes mellitus). Subjects with treated hypertension, treated hyperlipidemia, or treated thyroid disease will not be excluded provided they have been on stable therapy for at least 3 months;
* Had any major surgical procedure within the past 6 months including hysterectomy, hysterectomy with bilateral salpingo oophorectomy, or vaginal incontinence surgery
* Are receiving treatment with systemic glucocorticosteroids, sex steroid hormones such as androgens (eg, dehydroepiandrosterone [DHEA]) or gestagens (eg, anabolic steroids) and using any post menopausal hormone therapy;
* Have a history of severe or multiple drug allergies, severe adverse drug reaction or drug-related leucopenia;
* Have a history of nasal disorders (eg, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis), sinus disease or nasal surgery and/or seasonal or perennial allergic rhinitis in the active phase;
* Be using any form of chronic intranasal medication delivery, specifically nasal corticosteroids or decongestants;
* Have a diagnosis of sleep apnea and be using a continuous positive airway pressure/automatic positive airway device;
* Have a history of diagnosed hirsutism, alopecia or clinically significant acne;
* Have a history of diagnosed polycystic ovarian syndrome;
* Have pelvic inflammatory disease, chronic urinary tract, vaginal, or cervical infections, interstitial cystitis, vulvodynia, or significant symptomatic vaginal atrophy;
* Are currently pregnant, by history or positive serum pregnancy test at Screening Visit or have been pregnant within the 12 months prior to Screening Visit;
* Is breast feeding or have breast fed within the 6 months prior to Screening Visit;
* Are positive for hepatitis B-surface antigen, hepatitis C, or Human Immunodeficiency Virus (HIV);
* Have abnormal thyroid stimulating hormone level;
* For pre-menopausal women, have SHBG value <18 86 nmol/L; For post-menopausal women, have SHBG value >160 nmol/L
* Have any medical or psychiatric condition, physical examination finding, or laboratory result which, in the opinion of the principal investigator, would put the subject at additional medical risk or make her unlikely to be able to comply with study requirements; or
* Have received any drug as part of a research study within 30 days prior to the Screening Visit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
253
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment hospital [2] 0 0
Keogh Institute for Medical Research - Nedlands
Recruitment hospital [3] 0 0
The Robinson Institute University of Adelaide - North Adelaide
Recruitment hospital [4] 0 0
Barbara Gross Research Unit - Randwick
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Illinois
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Kansas
Country [10] 0 0
United States of America
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Maryland
Country [11] 0 0
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Michigan
Country [12] 0 0
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Minnesota
Country [13] 0 0
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Montana
Country [14] 0 0
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Nebraska
Country [15] 0 0
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New York
Country [16] 0 0
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North Carolina
Country [17] 0 0
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North Dakota
Country [18] 0 0
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Ohio
Country [19] 0 0
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Pennsylvania
Country [20] 0 0
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Tennessee
Country [21] 0 0
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Texas
Country [22] 0 0
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Virginia
Country [23] 0 0
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Washington
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
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Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Manitoba
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Acerus Pharmaceuticals Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.
Trial website
https://clinicaltrials.gov/study/NCT01607658
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalia Tkachenko, MD
Address 0 0
Trimel Pharmaceuticals Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01607658