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Trial Outcomes & Findings for Recombinant Human Prolactin for Lactation Induction (NCT NCT00181623)

NCT ID: NCT00181623

Last Updated: 2017-12-11

Results Overview

Treatment group

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

28 days

Results posted on

2017-12-11

Participant Flow

2005-2008 Academic Hospital, clinical research center

Participant milestones

Participant milestones
Measure
Recombinant Human Prolactin Treatment
Open label twice daily recombinant human prolactin 60 mcg/kg Recombinant Human Prolactin :
Overall Study
STARTED
6
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recombinant Human Prolactin for Lactation Induction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Recombinant Human Prolactin Treatment
n=6 Participants
Open label twice daily recombinant human prolactin Recombinant Human Prolactin :
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
30 years
STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: One subject did not qualify after screening.

Treatment group

Outcome measures

Outcome measures
Measure
Recombinant Human Prolactin Treatment
n=5 Participants
Open label twice daily recombinant human prolactin Recombinant Human Prolactin :
Breast Milk Production
66.1 mL/day
Standard Error 8.3

SECONDARY outcome

Timeframe: 28 days

Treatment group

Outcome measures

Outcome measures
Measure
Recombinant Human Prolactin Treatment
n=5 Participants
Open label twice daily recombinant human prolactin Recombinant Human Prolactin :
Breast Milk Prolactin Levels
118 mcg/L
Standard Error 25

Adverse Events

Recombinant Human Prolactin Treatment

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Recombinant Human Prolactin Treatment
n=5 participants at risk
Open label twice daily recombinant human prolactin Recombinant Human Prolactin :
Nervous system disorders
Tingling in hands
20.0%
1/5 • Number of events 1
Skin and subcutaneous tissue disorders
Red marks at injection site
20.0%
1/5 • Number of events 1
Nervous system disorders
Tiredness
20.0%
1/5 • Number of events 1

Additional Information

Corrine Welt, MD

Massachusetts General Hospital

Phone: 617-716-8437

Results disclosure agreements

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