A Study Comparing Subcutaneous Injection of Sayana Press In the Upper Arm Versus Anterior Thigh and Abdomen

Launched by PFIZER · May 14, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how well a contraceptive injection called Sayana Press works when given in different places on the body: the upper arm versus the anterior thigh and abdomen. The study is specifically for healthy women aged 18 to 45 who are not at high risk of becoming pregnant and have regular menstrual cycles. Participants must not have had a similar injection in the past year and should meet certain health criteria, including a specific body weight range.

If you qualify and choose to participate, you’ll receive an injection of Sayana Press and researchers will monitor how your body absorbs the medication. This is important to understand the best way to administer the injection for effectiveness. The study is currently recruiting participants, so if you or someone you know fits the eligibility criteria and is interested in learning more, it could be a great opportunity to contribute to important research in women's health.

Gender

FEMALE

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.