Trial Outcomes & Findings for The Safety and Efficacy of Recombinant Human Prolactin (NCT NCT00438490)

NCT ID: NCT00438490

Last Updated: 2018-01-03

Results Overview

Galactorrhea is breast milk production.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2018-01-03

Participant Flow

Participant milestones

Measure	Placebo Normal Saline Placebo once daily	Recombinant Human Prolactin Recombinant Human Prolactin 60 mcg/kg once daily
Overall Study STARTED	12	9
Overall Study COMPLETED	12	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety and Efficacy of Recombinant Human Prolactin

Baseline characteristics by cohort

Measure	Placebo n=12 Participants	Recombinant Human Prolactin n=9 Participants RhProlactin once daily Recombinant Human Prolactin :	Total n=21 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
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 4.0 • n=5 Participants	27.9 years STANDARD_DEVIATION 6.4 • n=7 Participants	28.4 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Galactorrhea is breast milk production.

Outcome measures

Measure	Placebo n=12 Participants	Recombinant Human Prolactin n=9 Participants RhProlactin once daily Recombinant Human Prolactin :
Galactorrhea	0 percentage of participants	56 percentage of participants

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Measure	Placebo n=9 Participants	Recombinant Human Prolactin n=12 Participants RhProlactin once daily Recombinant Human Prolactin :
N-telopeptide	7.4 nM/mM Standard Error 1.8	6.9 nM/mM Standard Error 0.7

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	Placebo n=12 Participants	Recombinant Human Prolactin n=9 Participants RhProlactin once daily Recombinant Human Prolactin :
Menstrual Cycle Length	28.8 Days Standard Error 1.0	30.1 Days Standard Error 1.1

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Measure	Placebo n=12 Participants	Recombinant Human Prolactin n=9 Participants RhProlactin once daily Recombinant Human Prolactin :
Estradiol	634 pmol/L Standard Error 175	467 pmol/L Standard Error 72

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Recombinant Human Prolactin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=12 participants at risk Placebo	Recombinant Human Prolactin n=9 participants at risk RhProlactin once daily Recombinant Human Prolactin :
General disorders fatigue	8.3% 1/12 • Number of events 1 • Course of the entire study	11.1% 1/9 • Number of events 1 • Course of the entire study
General disorders moodiness	0.00% 0/12 • Course of the entire study	11.1% 1/9 • Number of events 1 • Course of the entire study
Blood and lymphatic system disorders Enlarged Lymph node	0.00% 0/12 • Course of the entire study	11.1% 1/9 • Number of events 1 • Course of the entire study
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • Course of the entire study	0.00% 0/9 • Course of the entire study
Gastrointestinal disorders Nausea	16.7% 2/12 • Number of events 2 • Course of the entire study	0.00% 0/9 • Course of the entire study
General disorders Headache	25.0% 3/12 • Number of events 3 • Course of the entire study	0.00% 0/9 • Course of the entire study
General disorders Fever	8.3% 1/12 • Number of events 1 • Course of the entire study	0.00% 0/9 • Course of the entire study
Skin and subcutaneous tissue disorders Bruising from blood draw	8.3% 1/12 • Number of events 1 • Course of the entire study	0.00% 0/9 • Course of the entire study

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