The Safety and Efficacy of Recombinant Human Prolactin

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00438490
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 107
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Recombinant Human Prolactin	Phase 2

Detailed Description

There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: recombinant human prolactin Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection	Drug: Recombinant Human Prolactin
Placebo Comparator: Placebo Normal saline placebo subcutaneous injection	Drug: Recombinant Human Prolactin

Outcome Measures

Primary Outcome Measures

1. Galactorrhea [7 days]

   Galactorrhea is breast milk production.

Secondary Outcome Measures

1. N-telopeptide [7 days]

2. Menstrual Cycle Length [28 days]

3. Estradiol [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Healthy Subjects will meet the following criteria:

1. 18 to 40 years of age

2. Normal weight (BMI 17 to £ 30 kg/m2)

3. Good general health

4. On no medications for at least 3 months before the study

5. Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level

6. No evidence of androgen excess

7. Normal TSH, prolactin and hematocrit

8. No current interest in conception

9. No history of osteoporosis

10. No use of medications known to affect bone turnover

11. No alcoholism

12. No smoking

13. No history of medical problems or treatment known to affect bone turnover.

Exclusion Criteria:

Subjects will be excluded for pregnancy or evidence of breast masses.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corrine Welt	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Corrine K. Welt, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corrine Welt, Associate Professor of Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00438490
• Other Study ID Numbers: 2001-P-001057
• First Posted: Feb 22, 2007
• Last Update Posted: Jan 3, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Corrine Welt, Associate Professor of Medicine, Massachusetts General Hospital: galactorrhea; prolactin; bone turnover; menstrual cycle; Control Groups; Women

Study Results

Participant Flow

Arm/Group Title	Placebo	Recombinant Human Prolactin
Arm/Group Description	Normal Saline Placebo once daily	Recombinant Human Prolactin 60 mcg/kg once daily
Period Title: Overall Study
STARTED	12	9
COMPLETED	12	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Recombinant Human Prolactin	Total
Arm/Group Description	RhProlactin once daily Recombinant Human Prolactin :	Total of all reporting groups
Overall Participants	12	9	21
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	9 100%	21 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.1 (4.0)	27.9 (6.4)	28.4 (5.4)
Sex: Female, Male (Count of Participants)
Female	12 100%	9 100%	21 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	9 100%	21 100%

Outcome Measures

1. Primary Outcome

Title	Galactorrhea
Description	Galactorrhea is breast milk production.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Recombinant Human Prolactin
Arm/Group Description	RhProlactin once daily Recombinant Human Prolactin :
Measure Participants	12	9
Number [percentage of participants]	0 0%	56 622.2%

2. Secondary Outcome

Title	N-telopeptide
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Recombinant Human Prolactin	Placebo
Arm/Group Description	Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection Recombinant Human Prolactin	Normal saline placebo subcutaneous injection Recombinant Human Prolactin
Measure Participants	9	12
Mean (Standard Error) [nM/mM]	7.4 (1.8)	6.9 (0.7)

3. Secondary Outcome

Title	Menstrual Cycle Length
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Recombinant Human Prolactin
Arm/Group Description	Normal Saline Placebo once daily	Recombinant Human Prolactin 60 mcg/kg once daily
Measure Participants	12	9
Mean (Standard Error) [Days]	28.8 (1.0)	30.1 (1.1)

4. Secondary Outcome

Title	Estradiol
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Recombinant Human Prolactin
Arm/Group Description	Normal Saline Placebo once daily	Recombinant Human Prolactin 60 mcg/kg once daily
Measure Participants	12	9
Mean (Standard Error) [pmol/L]	634 (175)	467 (72)

Adverse Events

Time Frame	Course of the entire study
Arm/Group Title	Placebo		Recombinant Human Prolactin
Arm/Group Description	Placebo		RhProlactin once daily Recombinant Human Prolactin :
All Cause Mortality
	Placebo		Recombinant Human Prolactin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Recombinant Human Prolactin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Recombinant Human Prolactin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/12 (75%)		3/9 (33.3%)
Blood and lymphatic system disorders
Enlarged Lymph node	0/12 (0%)	0	1/9 (11.1%)	1
Gastrointestinal disorders
Diarrhea	1/12 (8.3%)	1	0/9 (0%)	0
Nausea	2/12 (16.7%)	2	0/9 (0%)	0
General disorders
fatigue	1/12 (8.3%)	1	1/9 (11.1%)	1
moodiness	0/12 (0%)	0	1/9 (11.1%)	1
Headache	3/12 (25%)	3	0/9 (0%)	0
Fever	1/12 (8.3%)	1	0/9 (0%)	0
Skin and subcutaneous tissue disorders
Bruising from blood draw	1/12 (8.3%)	1	0/9 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.