Clinical trial NCT01607658: Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Orgasmic Disorder
Keywords: Testosterone
Lead sponsor: Acerus Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2012-05-30
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

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.

Primary outcomes:
measure: Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
timeFrame: 84 days
Secondary outcomes:
measure: Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)
timeFrame: Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)
measure: Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84
timeFrame: Day 0 and Day 84
measure: Change in Global Sexual Functioning From Day 0 to Day 84
timeFrame: Day 0 and Day 84
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center Inc.
state: Alabama
city: Chandler
country: United States
facility: Radiant Research Inc.
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical Research Center
state: Arizona
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Denver
country: United States
facility: Radiant Research Inc.
state: Colorado
city: Groton
country: United States
facility: Thameside OB/GYN Centre
state: Connecticut
city: Hartford
country: United States
facility: Greater Hartford Women's Health Associates
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc.
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Oviedo
country: United States
facility: Compass Research East LLC
state: Florida
city: West Palm Beach
country: United States
facility: Center for Marital and Sexual Health of South Florida
state: Florida
city: Roswell
country: United States
facility: Atlanta North Gynecology, PC
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Chicago
country: United States
facility: Radiant Research Inc.
state: Illinois
city: Overland Park
country: United States
facility: Radiant Reseach
state: Kansas
city: Lutherville
country: United States
facility: Maryland Center for Sexual Health
state: Maryland
city: Bingham Farms
country: United States
facility: QUEST Research Institute
state: Michigan
city: Edina
country: United States
facility: Radiant Research Inc.
state: Minnesota
city: Billings
country: United States
facility: Montana Health Research Institute
state: Montana
city: Lincoln
country: United States
facility: Womens Clinic of Lincoln P.C.
state: Nebraska
city: New York
country: United States
facility: Columbia University School of Nursing
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Beachwood
country: United States
facility: Center for Marital and Sexual Health Inc.
state: Ohio
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: Mayfield Heights
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: West Chester
country: United States
facility: Cincinnati Urogynecology Associates (TRIHEALTH)
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia LLC
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Research Associates, Inc
state: Tennessee
city: Dallas
country: United States
facility: Radiant Research Inc.
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Radiant Research Inc.
state: Texas
city: San Antonio
country: United States
facility: San Antonio Psychiatric Research Center Dba Croft Group Research Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Center for Psychiatric Clinical Research
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Norfolk
country: United States
facility: Tidewater Physicians for Women
state: Virginia
city: Seattle
country: United States
facility: Women's Clincial Research Center
state: Washington
city: Melbourne
country: Australia
facility: Monash University
city: Nedlands
country: Australia
facility: Keogh Institute for Medical Research
city: North Adelaide
country: Australia
facility: The Robinson Institute University of Adelaide
city: Randwick
country: Australia
facility: Barbara Gross Research Unit
city: Edmonton
country: Canada
facility: Alta Clinical Research Inc.
state: Alberta
city: Coquitlam
country: Canada
facility: Gain Medical Centre
state: British Columbia
city: Victoria
country: Canada
facility: Discovery Clinical Services, Ltd
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Clinical Research Inc
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
Study officials:
affiliation: Trimel Pharmaceuticals Corporation
name: Natalia Tkachenko, MD
role: STUDY_DIRECTOR
References: