Healthy
Conditions
Keywords
galactorrhea, prolactin, bone turnover, menstrual cycle, Control Groups, Women
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.
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.
Interventions
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Galactorrhea | 7 days | Galactorrhea is breast milk production. |
Secondary
| Measure | Time frame |
|---|---|
| N-telopeptide | 7 days |
| Menstrual Cycle Length | 28 days |
| Estradiol | 7 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 12 |
| Recombinant Human Prolactin RhProlactin once daily
Recombinant Human Prolactin : | 9 |
| Total | 21 |
Baseline characteristics
| Characteristic | Recombinant Human Prolactin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 12 Participants | 21 Participants |
| Age, Continuous | 27.9 years STANDARD_DEVIATION 6.4 | 29.1 years STANDARD_DEVIATION 4 | 28.4 years STANDARD_DEVIATION 5.4 |
| Region of Enrollment United States | 9 participants | 12 participants | 21 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 12 | 3 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
Galactorrhea
Galactorrhea is breast milk production.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Galactorrhea | 0 percentage of participants |
| Recombinant Human Prolactin | Galactorrhea | 56 percentage of participants |
Secondary
Estradiol
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Estradiol | 634 pmol/L | Standard Error 175 |
| Recombinant Human Prolactin | Estradiol | 467 pmol/L | Standard Error 72 |
Secondary
Menstrual Cycle Length
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Menstrual Cycle Length | 28.8 Days | Standard Error 1 |
| Recombinant Human Prolactin | Menstrual Cycle Length | 30.1 Days | Standard Error 1.1 |
Secondary
N-telopeptide
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | N-telopeptide | 7.4 nM/mM | Standard Error 1.8 |
| Recombinant Human Prolactin | N-telopeptide | 6.9 nM/mM | Standard Error 0.7 |