Contraception
Conditions
Keywords
AE adverse event, DCF data collection forms, DMC Data Monitoring Committee, FDA U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU International units, mg milligram(s), SAE serious adverse event, µg microgram, ULN upper limit of the normal range
Brief summary
A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception
Detailed description
A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm
Interventions
DRUGMedroxyprogesterone acetate
Injectable hormonal contraceptive
Sponsors
Eastern Virginia Medical School
FHI 360
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-40 * negative pregnancy test on day of injection * not wishing to become pregnant in the next 12 months * at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD) * body mass index of 18-30
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) | 120 days following injection |
| Tmax (Time to Cmax) | 120 days following injection |
| AUC 0-91 (Area Under Curve) | first 91 days following injection |
| MPA Concentration at Day 91 (C91) | day 91 after first injection |
| MPA Concentration at Day 104 (C104) | day 104 after injection |
| MPA Concentration at Day 120 (C120) | day 120 after injection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medroxyprogesterone Acetate Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Medroxyprogesterone Acetate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 26 |
| serious Total, serious adverse events | 2 / 26 |
Outcome results
Primary
AUC 0-91 (Area Under Curve)
Time frame: first 91 days following injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medroxyprogesterone Acetate | AUC 0-91 (Area Under Curve) | 45.1 ng day/mL | Standard Deviation 14.5 |
Primary
Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
Time frame: 120 days following injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medroxyprogesterone Acetate | Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA)) | 0.953 ng/mL | Standard Deviation 0.308 |
Primary
MPA Concentration at Day 104 (C104)
Time frame: day 104 after injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medroxyprogesterone Acetate | MPA Concentration at Day 104 (C104) | 0.366 ng/mL | Standard Deviation 0.278 |
Primary
MPA Concentration at Day 120 (C120)
Time frame: day 120 after injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medroxyprogesterone Acetate | MPA Concentration at Day 120 (C120) | 0.327 ng/mL | Standard Deviation 0.206 |
Primary
MPA Concentration at Day 91 (C91)
Time frame: day 91 after first injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medroxyprogesterone Acetate | MPA Concentration at Day 91 (C91) | 0.427 ng/mL | Standard Deviation 0.354 |
Primary
Tmax (Time to Cmax)
Time frame: 120 days following injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medroxyprogesterone Acetate | Tmax (Time to Cmax) | 8 days |