12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress

• Sponsor: Sprout Pharmaceuticals, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01040208
• Collaborator: (none)
• Enrollment: 111
• Locations: 42
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunctions, Psychological; Depression	Drug: flibanserin 50 mg to 100 mg qhs; Drug: flibanserin 100 mg qhs; Drug: placebo 2 tablets qhs	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: flibanserin 50 mg to 100 mg qhs Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs	Drug: flibanserin 50 mg to 100 mg qhs; 50 to 100mg qhs
Experimental: flibanserin 100 mg qhs Patient to receive 2 flibanserin tablets of 50 mg qhs	Drug: flibanserin 100 mg qhs; 100mg qhs
Experimental: placebo 2 tablets qhs Patient to receive 2 placebo tablets of 50 mg qhs	Drug: placebo 2 tablets qhs; 50 mg placebo

Outcome Measures

Primary Outcome Measures

1. The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period. [17 weeks]

Secondary Outcome Measures

1. The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12) [12 weeks]

2. The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12) [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Women 18-50 years of age, not postmenopausal at the Screen Visit

2. Women with mild/remitted depressive disorder with score of <11 on the Quick Inventory of Depressive Symptoms Self Report and <16 on the Beck Anxiety Inventory at Screen/Baseline Visits

3. Women with decreased sexual desire and distress present at least 4 weeks at Screen Visit as determined by the Clinical Interview for Female Sexual Dysfunction-Depression and Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR)

4. Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline Visits

5. Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at Screen/Baseline Visits

6. Patients must be taking the same Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor for 3 months and be on a stable dose at least 2 months before the Screen Visit and remain on this regimen during the trial and for 1 month after trial completion

7. Patients must have had no treatment for Female Sexual Dysfunction 2 months before Screen Visit

8. Patients must use medically accepted contraception method

9. Patients must be in a secure, stable, monogamous, heterosexual relationship at least 12 months prior to Screen Visit, according to the Clinical Interview for Female Sexual Dysfunction-Depression

Exclusion criteria:

Conditions which may interfere with the ability to participate include, but are not limited to:

1. Patients who have taken any Prohibited Medications within 30 days before Baseline Visit

2. Patients with history of drug dependence/abuse (including alcohol) within past year

3. Patients with history of participation in a trial of another investigational drug within 1 month prior to the Screen Visit, or participation in previous flibanserin study

4. Women with lifelong decreased sexual desire (or Hypoactive Sexual Desire Disorder), Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, per DSM IV-TR criteria

5. Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction other than Selective Serotonin Reuptake Inhibitor/Norepinephrine Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia, or Sexual Dysfunction Due to a General Medical Condition

6. Patients who have had a hysterectomy, or are in the post menopause stage (i.e., bilateral oophorectomy, chemically induced menopause)

7. Patients with history of pelvic inflammatory disease, urinary tract, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, significant vaginal atrophy in the 4 weeks before the Screen Visit

8. Patients who are breastfeeding or have breastfed within 6 months prior to the Baseline Visit.

9. Patients who are pregnant (by serum pregnancy test) or have been pregnant within 6 months prior to the Baseline Visit

10. Patients with current Depressive Disorder (may have concurrent mild Anxiety Disorder) not adequately controlled during the last 2 months and/or with a score of <11 on the Quick Inventory of Depressive Symptoms Self Report and/or a score of <16 on the Beck Anxiety Inventory at Screen and/or Baseline Visits

11. Patients with history of suicide attempt within the last year or current suicidal ideation. Investigator must assess history of suicidality to determine if patient is at risk before entering the trial

12. Patients with history of other psychiatric disorders that could impact sexual function, risks patient safety, or may impact compliance. Axis I disorders (except anxiety symptoms and disorders) are excluded. Axis II disorders are allowed

13. Patients with significant cardiac, neurologic, hepatic, renal, hematologic, respiratory, gastrointestinal, immunological, endocrine disease

14. Patients with history of breast cancer or other cancer within the last 5 years, other than non-invasive, previously resected skin cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Innovations	Costa Mesa	California	United States	92636
2	Mood & Anxiety Research	Fresno	California	United States	93720
3	Synergy Clinical Research Center	National City	California	United States	91950
4	Clinical Innovations	Riverside	California	United States	92506
5	Schuster Medical Research	Sherman Oaks	California	United States	91403
6	Diablo Clinical Research	Walnut Creek	California	United States	94598
7	Western Affiliated Research Institute	Denver	Colorado	United States	80204
8	Radiant Research	Denver	Colorado	United States	80239
9	Ali Kashfi	Altamonte Springs	Florida	United States	32701
10	Gulf Coast Clinical Research	Fort Myers	Florida	United States	33912
11	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
12	Clinical Neuroscience Solutions	Jacksonville	Florida	United States	32216
13	Clinical Neuroscience Solutions	Orlando	Florida	United States	32806
14	Stedman Clinical Trials	Tampa	Florida	United States	33613
15	Kolin Research Group	Winter Park	Florida	United States	32789
16	Atlanta Institute of Medicine & Research	Atlanta	Georgia	United States	30328
17	Comprehensive Neuroscience	Atlanta	Georgia	United States	30328
18	Chicago Research Center	Chicago	Illinois	United States	60634
19	Capstone Clinical Research	Livertyville	Illinois	United States	60048
20	Psychiatric Medicine Associates	Skokie	Illinois	United States	60076
21	Clinco	Terre Haute	Indiana	United States	47802
22	Clinical Trials Technology	Prairie Village	Kansas	United States	66206
23	Sheppard Pratt Hospital	Baltimore	Maryland	United States	21285
24	ActivMed Practices and Research	Haverhill	Massachusetts	United States	01830
25	Millennium Psychiatric Associates	Creve Coeur	Missouri	United States	63141
26	Bio Behavioral Health	Toms River	New Jersey	United States	08755
27	Albuquerque Neuroscience	Albuquerque	New Mexico	United States	87109
28	Social Psychiatry Research Institute	Brooklyn	New York	United States	11235
29	Neurobehavioral Research	Cedarhurst	New York	United States	11516
30	Bioscience Research	Mount Kisco	New York	United States	10549
31	Medical and Behavioral Health Research	New York	New York	United States	10023
32	University of Cincinnati	Cincinnati	Ohio	United States	45219
33	MIdwest Clinical Research Center	Dayton	Ohio	United States	45408
34	IPS Research Company	Oklahoma City	Oklahoma	United States	73103
35	Suburban Research Associates	Media	Pennsylvania	United States	19063
36	CRI Worldwide	Philadelphia	Pennsylvania	United States	19139
37	Clinical Neuroscience Solutions	Memphis	Tennessee	United States	38119
38	Future Search Trials	Austin	Texas	United States	78756
39	Mary Ann Knesevich	Irving	Texas	United States	75062
40	Clinical Trials of Texas	San Antonio	Texas	United States	78229
41	San Antonio Psychiatric Research Center	San Antonio	Texas	United States	78240
42	Alliance Research Group	Richmond	Virginia	United States	23230

Sponsors and Collaborators

• Sprout Pharmaceuticals, Inc

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sprout Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01040208
• Other Study ID Numbers: 511.114
• First Posted: Dec 29, 2009
• Last Update Posted: Aug 24, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Sexual Dysfunctions, Psychological

Study Results

Participant Flow

Arm/Group Title	Flibanserin 50 mg to 100 mg Qhs (Take Daily, at Bedtime)	Flibanserin 100 mg Qhs	Placebo 2 Tablets Qhs
Arm/Group Description	Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs	Patient to receive 2 flibanserin tablets of 50 mg qhs	Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
Period Title: Overall Study
STARTED	45	28	38
COMPLETED	39	15	35
NOT COMPLETED	6	13	3

Baseline Characteristics

Arm/Group Title	Flibanserin 50 mg to 100 mg Qhs	Flibanserin 100 mg Qhs	Placebo 2 Tablets Qhs	Total
Arm/Group Description	Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs	Patient to receive 2 flibanserin tablets of 50 mg qhs	Patient to receive 2 flibanserin placebo tablets of 50 mg qhs	Total of all reporting groups
Overall Participants	45	28	38	111
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	45 100%	28 100%	38 100%	111 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.8 (7.2)	36.9 (8.0)	37.7 (7.1)	37.5 (7.3)
Sex: Female, Male (Count of Participants)
Female	45 100%	28 100%	38 100%	111 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	45 100%	28 100%	38 100%	111 100%

Outcome Measures

1. Primary Outcome

Title	The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
Time Frame	17 weeks

Outcome Measure Data

Analysis Population Description

The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.

Arm/Group Title	Flibanserin 50 mg to 100 mg Qhs	Flibanserin 100 mg Qhs	Placebo 2 Tablets Qhs
Arm/Group Description	Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs	Patient to receive 2 flibanserin tablets of 50 mg qhs	Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
Measure Participants	45	28	38
Number [participants]	16 35.6%	14 50%	32 84.2%

2. Secondary Outcome

Title	The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.

Arm/Group Title	Flibanserin 50 mg to 100 mg Qhs	Flibanserin 100 mg Qhs	Placebo 2 Tablets Qhs
Arm/Group Description
Measure Participants	45	28	38
Number [participants]	8 17.8%	6 21.4%	4 10.5%

3. Secondary Outcome

Title	The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.

Arm/Group Title	Flibanserin 50mg to 100mg Qhs	Flibanserin 100mg Qhs	Placebo 2 Tablets Qhs
Arm/Group Description	Group includes the 45 patients who took flibanserin 50 mg q.h.s. for the first 2 weeks followed by flibanserin 100 mg q.h.s.
Measure Participants	45	28	38
Number [participants]	8 17.8%	4 14.3%	1 2.6%

Adverse Events

Arm/Group Title	Flibanserin 50 mg to 100 mg Qhs		Flibanserin 100 mg Qhs		Placebo 2 Tablets Qhs
Arm/Group Description	Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs		Patient to receive 2 flibanserin tablets of 50 mg qhs		Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
All Cause Mortality
	Flibanserin 50 mg to 100 mg Qhs		Flibanserin 100 mg Qhs		Placebo 2 Tablets Qhs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Flibanserin 50 mg to 100 mg Qhs		Flibanserin 100 mg Qhs		Placebo 2 Tablets Qhs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/28 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Flibanserin 50 mg to 100 mg Qhs		Flibanserin 100 mg Qhs		Placebo 2 Tablets Qhs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/45 (35.6%)		14/28 (50%)		32/38 (84.2%)
Gastrointestinal disorders
Diarrhoea	2/45 (4.4%)	2	0/28 (0%)	0	2/38 (5.3%)	2
Dry mouth	3/45 (6.7%)	3	1/28 (3.6%)	1	1/38 (2.6%)	1
Nausea	0/45 (0%)	0	0/28 (0%)	0	2/38 (5.3%)	2
General disorders
Fatigue	2/45 (4.4%)	2	1/28 (3.6%)	1	2/38 (5.3%)	2
Infections and infestations
Nasopharyngitis	0/45 (0%)	0	2/28 (7.1%)	2	4/38 (10.5%)	4
Sinusitis	0/45 (0%)	0	2/28 (7.1%)	2	2/38 (5.3%)	2
Investigations
Weight increased	1/45 (2.2%)	1	0/28 (0%)	0	2/38 (5.3%)	2
Metabolism and nutrition disorders
Increased appetite	1/45 (2.2%)	1	1/28 (3.6%)	1	2/38 (5.3%)	2
Nervous system disorders
Headache	2/45 (4.4%)	2	2/28 (7.1%)	2	7/38 (18.4%)	7
Sedation	2/45 (4.4%)	2	1/28 (3.6%)	1	2/38 (5.3%)	2
Somnolence	0/45 (0%)	0	1/28 (3.6%)	1	3/38 (7.9%)	3
Psychiatric disorders
Insomnia	2/45 (4.4%)	2	2/28 (7.1%)	2	1/38 (2.6%)	2
Anxiety	1/45 (2.2%)	1	1/28 (3.6%)	1	2/38 (5.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.