Trial Outcomes & Findings for 6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA (NCT NCT00360243)

Last Updated: 2016-06-27

Results Overview

A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1385 participants

Primary outcome timeframe

24 weeks

Results posted on

2016-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Flibanserin 25 mg b.i.d 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d	Flibanserin 50mg Qhs 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs	Flibanserin 50mg b.i.d. 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d.	Placebo twice daily for 24 weeks placebo: placebo
Overall Study STARTED	337	363	336	349
Overall Study COMPLETED	235	243	180	224
Overall Study NOT COMPLETED	102	120	156	125

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flibanserin 25 mg b.i.d n=337 Participants 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d	Flibanserin 50mg Qhs n=363 Participants 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs	Flibanserin 50mg b.i.d. n=336 Participants 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d.	Placebo n=349 Participants twice daily for 24 weeks placebo: placebo	Total n=1385 Participants Total of all reporting groups
Age, Customized 18-34 years	154 participants n=5 Participants	169 participants n=7 Participants	145 participants n=5 Participants	158 participants n=4 Participants	626 participants n=21 Participants
Age, Customized 35-44 years	153 participants n=5 Participants	157 participants n=7 Participants	161 participants n=5 Participants	164 participants n=4 Participants	635 participants n=21 Participants
Age, Customized 45 years and older	30 participants n=5 Participants	37 participants n=7 Participants	30 participants n=5 Participants	27 participants n=4 Participants	124 participants n=21 Participants
Sex: Female, Male Female	337 Participants n=5 Participants	363 Participants n=7 Participants	336 Participants n=5 Participants	349 Participants n=4 Participants	1385 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
Race/Ethnicity, Customized White Non Hispanic	266 participants n=5 Participants	306 participants n=7 Participants	276 participants n=5 Participants	278 participants n=4 Participants	1126 participants n=21 Participants
Race/Ethnicity, Customized White Hispanic	20 participants n=5 Participants	20 participants n=7 Participants	23 participants n=5 Participants	19 participants n=4 Participants	82 participants n=21 Participants
Race/Ethnicity, Customized Black Non Hispanic	43 participants n=5 Participants	31 participants n=7 Participants	28 participants n=5 Participants	47 participants n=4 Participants	149 participants n=21 Participants
Race/Ethnicity, Customized Black Hispanic	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized Asian Non Hispanic	6 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	3 participants n=4 Participants	22 participants n=21 Participants
Race/Ethnicity, Customized Asian Hispanic	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/Ethnicity, Customized Missing	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.

Outcome measures

Outcome measures
Measure	Flibanserin 25 mg b.i.d n=320 Participants 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d	Flibanserin 50mg Qhs n=334 Participants 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs	Flibanserin 50mg b.i.d. n=291 Participants 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d.	Placebo n=325 Participants twice daily for 24 weeks placebo: placebo
Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.	1.5 SSEs per week Standard Deviation 3.4	1.6 SSEs per week Standard Deviation 4.2	1.6 SSEs per week Standard Deviation 3.5	1.6 SSEs per week Standard Deviation 4.3

PRIMARY outcome

Timeframe: baseline to 24 weeks

Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours / since your last visit." Potential responses included "no," "low," "moderate," or "strong" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire: 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire

Outcome measures

Outcome measures
Measure	Flibanserin 25 mg b.i.d n=320 Participants 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d	Flibanserin 50mg Qhs n=334 Participants 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs	Flibanserin 50mg b.i.d. n=291 Participants 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d.	Placebo n=325 Participants twice daily for 24 weeks placebo: placebo
Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.	8.8 units on a scale Standard Error 0.9	7.0 units on a scale Standard Error 0.9	7.7 units on a scale Standard Error 0.9	7.5 units on a scale Standard Error 0.9

Adverse Events

Flibanserin 25 mg b.i.d

Serious events: 1 serious events

Other events: 107 other events

Deaths: 0 deaths

Flibanserin 50mg Qhs

Serious events: 3 serious events

Other events: 126 other events

Deaths: 0 deaths

Flibanserin 50mg b.i.d.

Serious events: 1 serious events

Other events: 243 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flibanserin 25 mg b.i.d n=337 participants at risk 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d	Flibanserin 50mg Qhs n=363 participants at risk 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs	Flibanserin 50mg b.i.d. n=336 participants at risk 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d.	Placebo n=349 participants at risk twice daily for 24 weeks placebo: placebo
Infections and infestations Erythema infectiosum	0.00% 0/337	0.00% 0/363	0.00% 0/336	0.29% 1/349 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/337	0.28% 1/363 • Number of events 1	0.00% 0/336	0.00% 0/349
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer in situ	0.00% 0/337	0.00% 0/363	0.30% 1/336 • Number of events 1	0.00% 0/349
Hepatobiliary disorders Cholelithiasis	0.00% 0/337	0.28% 1/363 • Number of events 1	0.00% 0/336	0.00% 0/349
Infections and infestations Appendicitis	0.00% 0/337	0.28% 1/363 • Number of events 1	0.00% 0/336	0.00% 0/349
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.30% 1/337 • Number of events 1	0.00% 0/363	0.00% 0/336	0.00% 0/349

Other adverse events

Other adverse events
Measure	Flibanserin 25 mg b.i.d n=337 participants at risk 25 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 25 mg b.i.d	Flibanserin 50mg Qhs n=363 participants at risk 50 mg taken once daily at bedtime for 24 weeks flibanserin: Experimental: flibanserin 50mg qhs	Flibanserin 50mg b.i.d. n=336 participants at risk 50 mg twice daily for 24 weeks flibanserin: Experimental: flibanserin 50mg b.i.d.	Placebo n=349 participants at risk twice daily for 24 weeks placebo: placebo
Nervous system disorders Somnolence	6.5% 22/337 • Number of events 22	4.7% 17/363 • Number of events 17	17.3% 58/336 • Number of events 58	4.0% 14/349 • Number of events 14
Gastrointestinal disorders Nausea	6.2% 21/337 • Number of events 21	7.2% 26/363 • Number of events 26	14.3% 48/336 • Number of events 48	3.2% 11/349 • Number of events 11
Nervous system disorders Dizziness	2.7% 9/337 • Number of events 9	6.3% 23/363 • Number of events 23	17.0% 57/336 • Number of events 57	2.0% 7/349 • Number of events 7
Nervous system disorders Headache	6.8% 23/337 • Number of events 23	6.1% 22/363 • Number of events 22	7.7% 26/336 • Number of events 26	6.0% 21/349 • Number of events 21
Nervous system disorders Fatigue	3.3% 11/337 • Number of events 11	3.9% 14/363 • Number of events 14	12.2% 41/336 • Number of events 41	2.6% 9/349 • Number of events 9
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	6.2% 21/337 • Number of events 21	6.6% 24/363 • Number of events 24	3.9% 13/336 • Number of events 13	4.6% 16/349 • Number of events 16

Additional Information

Krista Barbour, Ph.D.

Sprout Pharmaceuticals

Phone: 9198820850

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place