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Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01607658
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Acerus Pharmaceuticals Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Female Orgasmic Disorder
Interventions Drug: Placebo
Drug: Low dose TBS-2
Drug: Medium dose TBS-2
Drug: High dose TBS-2
Enrollment 253
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Hide Arm/Group Description

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

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

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

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

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

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

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

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

Period Title: Overall Study
Started 65 67 58 63
Completed 56 56 47 52
Not Completed 9 11 11 11
Arm/Group Title Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2 Total
Hide Arm/Group Description

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

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

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

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

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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 65 67 58 63 253
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 67 participants 58 participants 63 participants 253 participants
42.4  (12.36) 44.5  (12.09) 44.3  (11.64) 42.4  (11.47) 43.4  (11.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 58 participants 63 participants 253 participants
Female
65
 100.0%
67
 100.0%
58
 100.0%
63
 100.0%
253
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 58 participants 63 participants 253 participants
Hispanic or Latino
3
   4.6%
10
  14.9%
6
  10.3%
9
  14.3%
28
  11.1%
Not Hispanic or Latino
62
  95.4%
57
  85.1%
52
  89.7%
54
  85.7%
225
  88.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 58 participants 63 participants 253 participants
American Indian or Alaska Native
0
   0.0%
2
   3.0%
0
   0.0%
1
   1.6%
3
   1.2%
Asian
2
   3.1%
0
   0.0%
0
   0.0%
3
   4.8%
5
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.5%
0
   0.0%
0
   0.0%
1
   0.4%
Black or African American
14
  21.5%
11
  16.4%
11
  19.0%
10
  15.9%
46
  18.2%
White
47
  72.3%
51
  76.1%
46
  79.3%
47
  74.6%
191
  75.5%
More than one race
2
   3.1%
2
   3.0%
1
   1.7%
1
   1.6%
6
   2.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
1
   0.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 58 participants 63 participants 253 participants
Canada
3
   4.6%
3
   4.5%
4
   6.9%
4
   6.3%
14
   5.5%
United States
53
  81.5%
58
  86.6%
48
  82.8%
55
  87.3%
214
  84.6%
Australia
9
  13.8%
6
   9.0%
6
  10.3%
4
   6.3%
25
   9.9%
1.Primary Outcome
Title Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
Hide Description [Not Specified]
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Hide Arm/Group Description:

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

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

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

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

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

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

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

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

Overall Number of Participants Analyzed 65 67 58 63
Mean (Standard Deviation)
Unit of Measure: orgasms
2.8  (4.60) 3.9  (5.22) 3.2  (4.70) 1.9  (3.47)
2.Secondary Outcome
Title Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)
Hide Description

as measured by Monash Women's Health Program Female Sexual Satisfaction Questionnaire (MONASH WHP FSSQ) question 11.

MONASH WHP FSSQ question 11 asks participants to comment on how satisfying they found the sex to be from "Not at all" to "Very much so". The lowest score is 1 and the highest is 9. All scores for each 28-day period were averaged. Change from baseline was obtained by subtracting baseline 28-day average from the 28-day period at the end of the study (Day 57 to 84).

Time Frame Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.
Arm/Group Title Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Hide Arm/Group Description:

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

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

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

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

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

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

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

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

Overall Number of Participants Analyzed 54 55 47 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.37  (1.624) 1.52  (1.586) 1.59  (1.803) 1.27  (1.707)
3.Secondary Outcome
Title Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84
Hide Description as measured by Female Sexual Distress Scale (FSDS-DAO) Question #15 on Day 0 and 84, respectively. Question #15 evaluates the level of distress related to problems with orgasm. It is rated on a 5-point Likert scale (from 0 to 4, i.e. never [0], rarely [1], occasionally [2], frequently [3], or always [4]). Higher scores indicate more distress.
Time Frame Day 0 and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.
Arm/Group Title Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Hide Arm/Group Description:

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

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

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

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

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

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

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

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

Overall Number of Participants Analyzed 56 56 47 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (1.09) -1.3  (1.40) -0.9  (1.10) -0.8  (1.23)
4.Secondary Outcome
Title Change in Global Sexual Functioning From Day 0 to Day 84
Hide Description as measured by Female Sexual Function Index (FSFI) on Day 0 and 84, respectively. The FSFI, a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual frustration in women. The questionnaire provides scores on 6 domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) as well as a total score. Fifteen items are rated on a 6-point Likert scale (from 0 to 5) and 4 items on a 5-point Likert scale (from 1 to 5). The scores are added and converted using a conversion factor so that the maximum score for each domain is 6. The overall FSFI score can range from 2 to 36. Higher scores indicate better or higher sexual function.
Time Frame Day 0 and Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.
Arm/Group Title Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Hide Arm/Group Description:

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

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

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

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

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

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

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

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

Overall Number of Participants Analyzed 53 55 47 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.90  (5.622) 3.42  (6.278) 3.33  (6.707) 3.35  (5.835)
Time Frame 84 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Hide Arm/Group Description

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

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

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

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

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

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

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

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

All-Cause Mortality
Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/67 (0.00%)   0/58 (0.00%)   0/63 (0.00%) 
Hide Serious Adverse Events
Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/67 (0.00%)   0/58 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo Low Dose TBS-2 Medium Dose TBS-2 High Dose TBS-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/65 (36.92%)   35/67 (52.24%)   20/58 (34.48%)   38/63 (60.32%) 
General disorders         
Fatigue   0/65 (0.00%)  0/67 (0.00%)  0/58 (0.00%)  2/63 (3.17%) 
Infections and infestations         
Upper Respiratory Tract Infection   4/65 (6.15%)  5/67 (7.46%)  2/58 (3.45%)  7/63 (11.11%) 
Nasopharyngitis   5/65 (7.69%)  0/67 (0.00%)  1/58 (1.72%)  0/63 (0.00%) 
Urinary Tract Infection   2/65 (3.08%)  0/67 (0.00%)  3/58 (5.17%)  1/63 (1.59%) 
Pharyngitis   1/65 (1.54%)  2/67 (2.99%)  0/58 (0.00%)  1/63 (1.59%) 
Sinusitis   3/65 (4.62%)  0/67 (0.00%)  0/58 (0.00%)  1/63 (1.59%) 
Injury, poisoning and procedural complications         
Contusion   0/65 (0.00%)  2/67 (2.99%)  0/58 (0.00%)  0/63 (0.00%) 
Investigations         
Urine Analysis Abnormal   0/65 (0.00%)  0/67 (0.00%)  2/58 (3.45%)  0/63 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia   1/65 (1.54%)  1/67 (1.49%)  2/58 (3.45%)  0/63 (0.00%) 
Nervous system disorders         
Headache   1/65 (1.54%)  2/67 (2.99%)  0/58 (0.00%)  2/63 (3.17%) 
Respiratory, thoracic and mediastinal disorders         
Nasal Inflamation   2/65 (3.08%)  4/67 (5.97%)  2/58 (3.45%)  5/63 (7.94%) 
Nasal Discomfort   1/65 (1.54%)  1/67 (1.49%)  0/58 (0.00%)  5/63 (7.94%) 
Nasal Mucosal Disorder   1/65 (1.54%)  1/67 (1.49%)  1/58 (1.72%)  2/63 (3.17%) 
Cough   2/65 (3.08%)  0/67 (0.00%)  1/58 (1.72%)  1/63 (1.59%) 
Epistaxis   0/65 (0.00%)  2/67 (2.99%)  1/58 (1.72%)  1/63 (1.59%) 
Nasal Congestion   0/65 (0.00%)  2/67 (2.99%)  1/58 (1.72%)  1/63 (1.59%) 
Rhinorrhoea   0/65 (0.00%)  3/67 (4.48%)  0/58 (0.00%)  0/63 (0.00%) 
Skin and subcutaneous tissue disorders         
Acne   0/65 (0.00%)  4/67 (5.97%)  3/58 (5.17%)  5/63 (7.94%) 
Hair Growth Abnormal   1/65 (1.54%)  3/67 (4.48%)  0/58 (0.00%)  5/63 (7.94%) 
Hirsutism   0/65 (0.00%)  2/67 (2.99%)  0/58 (0.00%)  3/63 (4.76%) 
Scab   1/65 (1.54%)  0/67 (0.00%)  0/58 (0.00%)  3/63 (4.76%) 
Alopecia   0/65 (0.00%)  2/67 (2.99%)  0/58 (0.00%)  1/63 (1.59%) 
Rash   0/65 (0.00%)  2/67 (2.99%)  1/58 (1.72%)  0/63 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nathan Bryson, Chief Scientific Officer
Organization: Acerus Pharmaceuticals Corporation
Phone: 1-416-679-0776
EMail: nbryson@aceruspharma.com
Layout table for additonal information
Responsible Party: Acerus Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01607658    
Other Study ID Numbers: TBS-2-AMB-2012-01
First Submitted: May 18, 2012
First Posted: May 30, 2012
Results First Submitted: March 28, 2018
Results First Posted: August 13, 2018
Last Update Posted: August 13, 2018