Trial Outcomes & Findings for Recombinant Human Prolactin for Lactation Induction (NCT NCT00181610)

NCT ID: NCT00181610

Last Updated: 2018-01-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2018-01-03

Participant Flow

2004-2008 Academic Hospital, clinical research center

Participant milestones

Measure	Placebo Twice Per Day Placebo group Normal Saline : twice per day	Recombinant Human Prolactin Twice Per Day Recombinant human prolactin every 12 hours Recombinant Human Prolactin : 60 mcg/kg every 12 hours	Recombinant Human Prolactin Alternating With Placebo Recombinant human prolactin alternating with placebo every 12 hours Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours
Overall Study STARTED	4	4	3
Overall Study COMPLETED	4	3	3
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recombinant Human Prolactin for Lactation Induction

Baseline characteristics by cohort

Measure	Placebo Twice Per Day n=4 Participants Placebo group Normal Saline : twice per day	Recombinant Human Prolactin Twice Per Day n=3 Participants Recombinant human prolactin every 12 hours Recombinant Human Prolactin : 60 mcg/kg every 12 hours	Recombinant Human Prolactin Once Per Day n=3 Participants Recombinant human prolactin alternating with placebo every 12 hours Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30 years STANDARD_DEVIATION 5 • n=5 Participants	30 years STANDARD_DEVIATION 5 • n=7 Participants	32 years STANDARD_DEVIATION 6 • n=5 Participants	32 years STANDARD_DEVIATION 5 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 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
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Measure	Placebo Twice Per Day n=4 Participants Placebo group Normal Saline : twice per day	Recombinant Human Prolactin Twice Per Day n=3 Participants Recombinant human prolactin every 12 hours Recombinant Human Prolactin : 60 mcg/kg every 12 hours	Recombinant Human Prolactin Alternating With Placebo n=3 Participants Recombinant human prolactin alternating with placebo every 12 hours Recombinant human prolactin : 60 mcg/kg given every 24 hours Placebo given every 24 hours
Change in Breast Milk Volume Baseline to 7 Days	-12 % change from baseline Standard Error 27	429 % change from baseline Standard Error 338	44 % change from baseline Standard Error 28

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Measure	Placebo Twice Per Day n=4 Participants Placebo group Normal Saline : twice per day	Recombinant Human Prolactin Twice Per Day n=3 Participants Recombinant human prolactin every 12 hours Recombinant Human Prolactin : 60 mcg/kg every 12 hours	Recombinant Human Prolactin Alternating With Placebo n=3 Participants Recombinant human prolactin alternating with placebo every 12 hours Recombinant human prolactin : 60 mcg/kg given every 24 hours Placebo given every 24 hours
Breast Milk Prolactin Levels	60 mcg/L Standard Error 13	118 mcg/L Standard Error 25	118 mcg/L Standard Error 25

Adverse Events

Placebo Twice Per Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Recombinant Human Prolactin Twice Per Day

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Recombinant Human Prolactin Once Per Day

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Twice Per Day n=4 participants at risk Placebo group Normal Saline : twice per day	Recombinant Human Prolactin Twice Per Day n=4 participants at risk Recombinant human prolactin every 12 hours Recombinant Human Prolactin : 60 mcg/kg every 12 hours	Recombinant Human Prolactin Once Per Day n=3 participants at risk Recombinant human prolactin alternating with placebo every 12 hours Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours
Skin and subcutaneous tissue disorders Red marks	75.0% 3/4 • Number of events 3	25.0% 1/4 • Number of events 1	66.7% 2/3 • Number of events 2
General disorders Tiredness	50.0% 2/4 • Number of events 2	25.0% 1/4 • Number of events 1	33.3% 1/3 • Number of events 1
General disorders headache	0.00% 0/4	25.0% 1/4 • Number of events 1	0.00% 0/3
Gastrointestinal disorders nausea	0.00% 0/4	0.00% 0/4	33.3% 1/3 • Number of events 1
Reproductive system and breast disorders Menses	0.00% 0/4	25.0% 1/4 • Number of events 1	0.00% 0/3
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4	0.00% 0/4	33.3% 1/3 • Number of events 1

Additional Information

Corrine Welt, MD

Massachusetts General Hospital

Phone: 617-726-8437

Email: cwelt@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place