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Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Palatin Technologies
ClinicalTrials.gov Identifier:
NCT01382719
First received: June 24, 2011
Last updated: December 2, 2014
Last verified: December 2014
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Female Sexual Arousal Disorder
Hypoactive Sexual Desire Disorder
Intervention: Drug: bremelanotide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 1142 subjects were screened at 69 medical sites in the US and Canada, 612 subjects were enrolled, and 488 subjects entered the single-blind placebo treatment period; 397 were randomized, and 394 were dosed with randomized treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 91 subjects were not randomized due to failing the resting blood pressure criteria (36), withdrawal of consent (24), being lost to follow-up (9), adverse events (5), non-compliance (5), and other reasons (12).

Reporting Groups
  Description
Placebo identical formulation without active ingredient
Bremelanotide Arm 1 low dose 0.75 mg BMT
Bremelanotide Arm 2 middle dose 1.25 mg BMT
Bremelanotide Arm 3 high dose 1.75 mg BMT

Participant Flow:   Overall Study
    Placebo   Bremelanotide Arm 1   Bremelanotide Arm 2   Bremelanotide Arm 3
STARTED   98   100   100   99 
Subjects Not Dosed   1   0   1   1 
COMPLETED   80   81   66   66 
NOT COMPLETED   18   19   34   33 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo identical formulation without active ingredient
Bremelanotide Arm 1 low dose 0.75 mg BMT
Bremelanotide Arm 2 middle dose 1.25 mg BMT
Bremelanotide Arm 3 high dose 1.75 mg BMT
Total Total of all reporting groups

Baseline Measures
   Placebo   Bremelanotide Arm 1   Bremelanotide Arm 2   Bremelanotide Arm 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   100   99   98   394 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.0  (7.70)   37.6  (7.76)   35.7  (7.22)   37.0  (7.56)   36.9  (7.57) 
Gender 
[Units: Participants]
         
Female   97   100   99   98   394 
Male   0   0   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
         
American Indian or Alaska Native   2   1   1   1   5 
Asian   0   0   0   2   2 
Native Hawaiian or Other Pacific Islander   1   0   0   0   1 
Black or African American   19   25   32   23   99 
White   75   71   65   70   281 
Other   0   3   0   2   5 
Unknown or Not Reported   0   0   1   0   1 
Weight 
[Units: Pound]
Mean (Standard Deviation)
 164.40  (42.050)   168.17  (37.867)   173.97  (43.229)   179.15  (45.872)   171.41  (42.532) 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 27.73  (6.171)   28.47  (6.616)   29.17  (7.096)   29.92  (7.181)   28.82  (6.802) 
Of Childbearing Potential 
[Units: Participants]
         
Of Childbearing Potential   72   76   70   65   283 
Surgically Sterile   25   24   29   32   110 
Data Missing   0   0   0   1   1 
Weight Quartile 
[Units: Pound]
         
95 - 143 pounds   37   21   23   21   102 
>143 - 165 pounds   18   36   25   24   103 
>165 - 200.6 pounds   23   26   28   24   101 
>200.6 - 350 pounds   19   17   23   28   87 
Data Missing   0   0   0   1   1 
Menses Frequency 
[Units: Participants]
         
Variable cycle length (<7 days different from nor   3   4   4   4   15 
Regular   72   75   86   79   312 
Variable cycle length (>7 days different from nor   7   2   1   2   12 
2 or more skipped cycles, and amenorrhea for 60 or   2   6   2   1   11 
N.A.   13   13   6   12   44 
Natural Hair Color 
[Units: Participants]
         
Red   6   5   6   6   23 
Other Than Red   91   95   93   92   371 
Diagnosis 
[Units: Participants]
         
FSAD   4   3   3   2   12 
HSDD   24   20   24   24   92 
Mixed FSAD/HSDD   69   77   72   72   290 
Oral Contraceptive Use within 30 Days of Visit 1 
[Units: Participants]
         
Yes   12   15   11   15   53 
No   85   85   88   83   341 


  Outcome Measures
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1.  Primary:   The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)   [ Time Frame: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period. ]

2.  Secondary:   Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index   [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ]

3.  Secondary:   Satisfaction With Arousal as Measured by GAQ Question 1   [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ]

4.  Secondary:   Desire Domain From Female Sexual Function Index   [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ]

5.  Secondary:   Satisfaction With Desire as Measured by GAQ Question 2   [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ]

6.  Secondary:   Quality of Relationship With Partner as Measured by GAQ Question 4   [ Time Frame: 4-12 weeks from baseline to end of study (total study duration 20 weeks) ]

7.  Secondary:   FSDS–DAO Total Score   [ Time Frame: 4 - 12 weeks from baseline to end of study (total study duration 20 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeffrey Edelson, MD, FRCPC
Organization: Palatin Technologies, Inc.
phone: (609) 495-2200
e-mail: jedelson@palatin.com



Responsible Party: Palatin Technologies
ClinicalTrials.gov Identifier: NCT01382719     History of Changes
Other Study ID Numbers: PT-141-54
Study First Received: June 24, 2011
Results First Received: September 5, 2013
Last Updated: December 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada