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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: March 7, 2014
Last verified: March 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  
Number of Participants  
[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
No text entered.


  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


No publications provided


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: March 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada