Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sprout Pharmaceuticals, Inc

ClinicalTrials.gov Identifier:

NCT01188603

First received: August 24, 2010

Last updated: March 14, 2012

Last verified: March 2012

History of Changes

Results First Received: May 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Sexual Dysfunctions, Psychological
Intervention:	Drug: flibanserin drug

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Flibanserin	100mg Flibanserin administered orally once daily

Participant Flow: Overall Study

	Flibanserin
STARTED	24
COMPLETED	24
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Flibanserin	100mg Flibanserin administered orally once daily

Baseline Measures

	Flibanserin
Number of Participants [units: participants]	24
Age [units: Years] Mean ± Standard Deviation	59.6 ± 8.3
Gender [units: Patients]
Female	24
Male	0
BMI ^[1] [units: kg/m^2] Mean ± Standard Deviation	28.25 ± 5.31

[1]	Body Mass Index

Outcome Measures

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1. Primary:

Flibanserin: AUC_0-∞ [ Time Frame: 8 days ]

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2. Primary:

Flibanserin: AUC τ,ss [ Time Frame: 8 days ]

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3. Primary:

Flibanserin: Cmax [ Time Frame: 8 days ]

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4. Primary:

Flibanserin: Cmax,ss [ Time Frame: 8 days ]

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5. Primary:

Flibanserin: Tmax [ Time Frame: 8 days ]

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6. Primary:

Flibanserin: Tmax,ss [ Time Frame: 8 days ]

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7. Secondary:

BIMA 23 BS: AUC_0-∞ [ Time Frame: 8 days ]

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8. Secondary:

BIMA 23 BS: AUC_τ,ss [ Time Frame: 8 days ]

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9. Secondary:

BIMA 23 BS: Cmax [ Time Frame: 8 days ]

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10. Secondary:

BIMA 23 BS: Cmax,ss [ Time Frame: 8 days ]

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11. Secondary:

BIMA 23 BS: Tmax [ Time Frame: 8 days ]

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12. Secondary:

BIMA 23 BS: Tmax,ss [ Time Frame: 8 days ]

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13. Secondary:

BIML 7 ZW: AUC_0-∞ [ Time Frame: 8 days ]

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14. Secondary:

BIML 7 ZW: AUC_τ,ss [ Time Frame: 8 days ]

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15. Secondary:

BIML 7 ZW: Cmax [ Time Frame: 8 days ]

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16. Secondary:

BIML 7 ZW: Cmax,ss [ Time Frame: 8 days ]

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17. Secondary:

BIML 7 ZW: Tmax [ Time Frame: 8 days ]

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18. Secondary:

BIML 7 ZW: Tmax,ss [ Time Frame: 8 days ]

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19. Secondary:

TFMPP: AUC_0-∞ [ Time Frame: 8 days ]

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20. Secondary:

TFMPP: AUC_τ,ss [ Time Frame: 8 days ]

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21. Secondary:

TFMPP: Cmax [ Time Frame: 8 days ]

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22. Secondary:

TFMPP: Cmax,ss [ Time Frame: 8 days ]

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23. Secondary:

TFMPP: Tmax [ Time Frame: 8 days ]

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24. Secondary:

TFMPP: Tmax,ss [ Time Frame: 8 days ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Sprout Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT01188603 History of Changes
Other Study ID Numbers:	511.146
Study First Received:	August 24, 2010
Results First Received:	May 4, 2011
Last Updated:	March 14, 2012
Health Authority:	United States: Food and Drug Administration

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