Trial Outcomes & Findings for Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder (NCT NCT01607658)
NCT ID: NCT01607658
Last Updated: 2018-08-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
253 participants
Primary outcome timeframe
84 days
Results posted on
2018-08-13
Participant Flow
Participant milestones
| Measure |
Placebo
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
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
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
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 Study
STARTED
|
65
|
67
|
58
|
63
|
|
Overall Study
COMPLETED
|
56
|
56
|
47
|
52
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
11
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=65 Participants
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
n=67 Participants
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
n=58 Participants
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
n=63 Participants
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
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 11.47 • n=4 Participants
|
43.4 years
STANDARD_DEVIATION 11.88 • n=21 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
253 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
225 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: ITT Population
Outcome measures
| Measure |
Placebo
n=65 Participants
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
n=67 Participants
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
n=58 Participants
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
n=63 Participants
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
|
|---|---|---|---|---|
|
Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
|
2.8 orgasms
Standard Deviation 4.60
|
3.9 orgasms
Standard Deviation 5.22
|
3.2 orgasms
Standard Deviation 4.70
|
1.9 orgasms
Standard Deviation 3.47
|
SECONDARY outcome
Timeframe: Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)Population: The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.
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).
Outcome measures
| Measure |
Placebo
n=54 Participants
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
n=55 Participants
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
n=47 Participants
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
n=54 Participants
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
|
|---|---|---|---|---|
|
Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)
|
1.37 units on a scale
Standard Deviation 1.624
|
1.52 units on a scale
Standard Deviation 1.586
|
1.59 units on a scale
Standard Deviation 1.803
|
1.27 units on a scale
Standard Deviation 1.707
|
SECONDARY outcome
Timeframe: Day 0 and Day 84Population: The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
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
n=56 Participants
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
n=47 Participants
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
n=53 Participants
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
|
|---|---|---|---|---|
|
Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84
|
-0.9 units on a scale
Standard Deviation 1.09
|
-1.3 units on a scale
Standard Deviation 1.40
|
-0.9 units on a scale
Standard Deviation 1.10
|
-0.8 units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Day 0 and Day 84Population: The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
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
n=55 Participants
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
n=47 Participants
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
n=54 Participants
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
|
|---|---|---|---|---|
|
Change in Global Sexual Functioning From Day 0 to Day 84
|
2.90 units on a scale
Standard Deviation 5.622
|
3.42 units on a scale
Standard Deviation 6.278
|
3.33 units on a scale
Standard Deviation 6.707
|
3.35 units on a scale
Standard Deviation 5.835
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Low Dose TBS-2
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Medium Dose TBS-2
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
High Dose TBS-2
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=65 participants at risk
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
n=67 participants at risk
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
n=58 participants at risk
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
n=63 participants at risk
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
|
|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.2%
4/65 • 84 days
|
7.5%
5/67 • 84 days
|
3.4%
2/58 • 84 days
|
11.1%
7/63 • 84 days
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
5/65 • 84 days
|
0.00%
0/67 • 84 days
|
1.7%
1/58 • 84 days
|
0.00%
0/63 • 84 days
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
2/65 • 84 days
|
0.00%
0/67 • 84 days
|
5.2%
3/58 • 84 days
|
1.6%
1/63 • 84 days
|
|
Infections and infestations
Pharyngitis
|
1.5%
1/65 • 84 days
|
3.0%
2/67 • 84 days
|
0.00%
0/58 • 84 days
|
1.6%
1/63 • 84 days
|
|
Infections and infestations
Sinusitis
|
4.6%
3/65 • 84 days
|
0.00%
0/67 • 84 days
|
0.00%
0/58 • 84 days
|
1.6%
1/63 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Inflamation
|
3.1%
2/65 • 84 days
|
6.0%
4/67 • 84 days
|
3.4%
2/58 • 84 days
|
7.9%
5/63 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
1.5%
1/65 • 84 days
|
1.5%
1/67 • 84 days
|
0.00%
0/58 • 84 days
|
7.9%
5/63 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mucosal Disorder
|
1.5%
1/65 • 84 days
|
1.5%
1/67 • 84 days
|
1.7%
1/58 • 84 days
|
3.2%
2/63 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
2/65 • 84 days
|
0.00%
0/67 • 84 days
|
1.7%
1/58 • 84 days
|
1.6%
1/63 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/65 • 84 days
|
3.0%
2/67 • 84 days
|
1.7%
1/58 • 84 days
|
1.6%
1/63 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/65 • 84 days
|
3.0%
2/67 • 84 days
|
1.7%
1/58 • 84 days
|
1.6%
1/63 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/65 • 84 days
|
4.5%
3/67 • 84 days
|
0.00%
0/58 • 84 days
|
0.00%
0/63 • 84 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/65 • 84 days
|
6.0%
4/67 • 84 days
|
5.2%
3/58 • 84 days
|
7.9%
5/63 • 84 days
|
|
Skin and subcutaneous tissue disorders
Hair Growth Abnormal
|
1.5%
1/65 • 84 days
|
4.5%
3/67 • 84 days
|
0.00%
0/58 • 84 days
|
7.9%
5/63 • 84 days
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/65 • 84 days
|
3.0%
2/67 • 84 days
|
0.00%
0/58 • 84 days
|
4.8%
3/63 • 84 days
|
|
Skin and subcutaneous tissue disorders
Scab
|
1.5%
1/65 • 84 days
|
0.00%
0/67 • 84 days
|
0.00%
0/58 • 84 days
|
4.8%
3/63 • 84 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/65 • 84 days
|
3.0%
2/67 • 84 days
|
0.00%
0/58 • 84 days
|
1.6%
1/63 • 84 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/65 • 84 days
|
3.0%
2/67 • 84 days
|
1.7%
1/58 • 84 days
|
0.00%
0/63 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • 84 days
|
1.5%
1/67 • 84 days
|
3.4%
2/58 • 84 days
|
0.00%
0/63 • 84 days
|
|
Investigations
Urine Analysis Abnormal
|
0.00%
0/65 • 84 days
|
0.00%
0/67 • 84 days
|
3.4%
2/58 • 84 days
|
0.00%
0/63 • 84 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/65 • 84 days
|
3.0%
2/67 • 84 days
|
0.00%
0/58 • 84 days
|
0.00%
0/63 • 84 days
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • 84 days
|
3.0%
2/67 • 84 days
|
0.00%
0/58 • 84 days
|
3.2%
2/63 • 84 days
|
|
General disorders
Fatigue
|
0.00%
0/65 • 84 days
|
0.00%
0/67 • 84 days
|
0.00%
0/58 • 84 days
|
3.2%
2/63 • 84 days
|
Additional Information
Dr. Nathan Bryson, Chief Scientific Officer
Acerus Pharmaceuticals Corporation
Phone: 1-416-679-0776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place