Clinical trial NCT04893798: A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and Abdomen
Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO COMPARE THE PHARMACOKINETICS AND RELATIVE BIOAVAILABILITY OF MEDROXYPROGESTERONE ACETATE IN HEALTHY FEMALE PARTICIPANTS FOLLOWING SUBCUTANEOUS INJECTION OF SAYANA PRESS IN THE UPPER ARM RELATIVE TO ANTERIOR THIGH AND ABDOMEN
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the pharmacokinetics and relative bioavailability of medroxyprogesterone in healthy female participants following subcutaneous injection of Sayana Press into the upper arm versus anterior thigh and abdomen.


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal female participants, 18 to 45 years of age, inclusive, at the time of signing the ICD who are at low risk of pregnancy
* Participants who have a regular menstrual cycle (between 21 and 42 days in length).
* No previous injection of depot MPA for 1 year prior to enrollment.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* History of abnormal cervical cytology within the last 3 years that has not been adequately treated (at least 2 subsequent normal smears). However, ASCUS is permitted in this study.
* Known or suspected malignancy of the breast or genital organs.
* Known with metabolic bone disease.
* Undiagnosed abnormal genital bleeding.
* Known or suspected pregnancy; or nursing females.
* History of febrile illness within 5 days prior to the first dose.
* Participant with active thrombophlebitis or whose medical history suggests that they may be at increased risk for osteoporosis, thromboembolic disease or cerebral vascular disease.
* Use of prescription or nonprescription drugs, vitamins, herbal preparations and dietary supplements capable of inducing hepatic metabolism (eg, barbiturates, rifampicin, carbamazepine or St John's Wort) or any medication known to be a
* cytochrome P450 inhibitor within 30 days (or 5 half-lives of the substance, whichever is longer) of enrollment in the study
* Use of hormonal contraception (including hormone releasing intrauterine device) within the last 3 months (and should have resumed regular menstruation).
* Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval \>450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is \>450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision
* making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.

Primary outcomes:
measure: Serum Trough Concentration (Ctrough) of Medroxyprogesterone
timeFrame: Day 92 post dose
measure: Area under the curve from time zero to end of dosing interval (AUCtau)
timeFrame: pre-dose, up to 92 days post dose
measure: Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone
timeFrame: pre-dose, up to 92 days post dose
Secondary outcomes:
measure: Serum Progesterone Level
timeFrame: pre-dose, up to 99 days post dose
measure: Serum Estradiol Level
timeFrame: pre-dose, up tp 99 days post dose
measure: Serum Luteinizing Hormone (LH) Level
timeFrame: pre-dose, up to 99 days post dose
measure: Serum Follicle-Stimulating Hormone (FSH) Level
timeFrame: pre-dose, up to 99 days post dose
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Informed consent document to 150 days post dose or until study completion, whichever is longer.
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: baseline, up to 150 days post dose or until study completion, whichever is longer
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
timeFrame: Screening, Day 1, up to 150 days post dose or until study completion, whichever is longer
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit - Brussels
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: