Trial Outcomes & Findings for Savella in Treatment for Provoked Vestibulodynia (NCT NCT01304589)

Results Overview

The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. "0" equals no pain to "45" equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

18 weeks

Results posted on

2018-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Milnacipran Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Overall Study STARTED	31
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Savella in Treatment for Provoked Vestibulodynia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Milnacipram n=31 Participants Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Pain Rating Index	20.0 units on a scale STANDARD_DEVIATION 8.9 • n=5 Participants
Tampon test	5.14 units on a scale STANDARD_DEVIATION 3.01 • n=5 Participants
coital pain	6.94 units on a scale STANDARD_DEVIATION 2.51 • n=5 Participants
24-hour vulvar pain	2.09 units on a scale STANDARD_DEVIATION 2.03 • n=5 Participants

PRIMARY outcome

Timeframe: 18 weeks

Population: 22 subjects were eligible and received study medication. Analysis population included all 22 eligible subjects.

The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. "0" equals no pain to "45" equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.

Outcome measures

Outcome measures
Measure	Milnacipram n=22 Participants Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Pain Rating Index	12.3 units on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: 18 weeks

Population: 22 subjects were eligible and received study medication. Analysis population includes all 22 eligible subjects.

"0" equals no pain with tampon insertion to "10" equals worse pain imaginable with tampon insertion. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.

Outcome measures

Outcome measures
Measure	Milnacipram n=22 Participants Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Tampon Pain	2.45 units on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: 18 weeks

Population: 22 subjects were assigned to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes the 18 eligible subjects who completed all of the study visits.

"0" equals no pain with intercourse to "10" equals worse imaginable pain with intercourse. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.

Outcome measures

Outcome measures
Measure	Milnacipram n=18 Participants Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Coital Pain	3.43 units on a scale Standard Deviation 2.82

SECONDARY outcome

Timeframe: 18 weeks

Population: 22 subjects were randomized to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes all 18 eligible subjects who completed all of the study visits.

"0" equals no vulvar pain within the last 24 hours to "10" equals worse imaginable vulvar pain within the last 24 hours. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.

Outcome measures

Outcome measures
Measure	Milnacipram n=18 Participants Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
24-hour Vulvar Pain	0.73 units on a scale Standard Deviation 0.99

Adverse Events

Milnacipram

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Milnacipram n=31 participants at risk Crossover study
Gastrointestinal disorders nausea	48.4% 15/31 • Number of events 20
Nervous system disorders headache	41.9% 13/31 • Number of events 15
General disorders hot flashes	22.6% 7/31 • Number of events 9
Nervous system disorders dizziness	19.4% 6/31 • Number of events 10

Additional Information

Dr. Candace Brown

University of Tennessee Health Science Center

Phone: 901-412-4341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place