A Study to Evaluate the Effect of a Contraceptive Vaginal Ring LSP-5415 Releasing Ethinyl Estradiol plus Etonogestrel on Ovarian Function in Healthy Adult Females

upin Research Inc0 sites0 target enrollmentStarted: TBDLast updated: October 17, 2022

Overview

No summary available.

•Must be able to read and write and willing to sign Informed Consent Form prior to study participation in accordance with legal requirements.
•2\.Females (18 to 35 years of age, inclusive) without uncontrolled concomitant disease at the Baseline Visit.
•3\.Have a regular menstrual cycle that is 24\-32 days in duration.
•4\.Cohort \#1 \- BMI of 18 kg/m2 to 30 kg/m2, inclusive. Cohort \#2 \- BMI \> 30 kg/m2 to Ã¢â?°Â¤ 35 kg/m2\.
•5\.Will not be at risk for pregnancy; subjects must agree to consistently use reliable non\-hormonal contraceptive methods (spermicide\-coated condoms, sterilization, male partnerÃ¢â?¬•s sterilization via vasectomy, or sexual abstinence), or be in a same\-sex relationship from screening through study completion or be surgically sterilized by bilateral tubal ligation.
•6\.Both ovaries and uterus must be intact, and visible on transvaginal ultrasound (TVUS) examination during screening.
•7\.Subjects must be in good physical and mental health as determined by vital signs, medical history and clinical examination.
•8\.Subjects must have a blood pressure reading in a sitting position, between 90\-140 mmHg (systolic) and 50\-90 mmHg (diastolic) and pulse rate between 50 and 100 bpm.
•9\.Be at least 3 months after a delivery or abortion.
•10\.Be at least six months since last progestin injection with one or more spontaneous menses.

•1\. Pregnancy, a positive serum Ã?Â²\-hCG pregnancy test at screening or lactation.
•2\.Use of tobacco\- or nicotine\-containing products within 6 months prior to study drug administration on Day 1 of treatment cycle 1\.
•3\.Have a history of cervical carcinoma or other carcinomas of the vagina or vulva.
•4\. Subjects with abnormal pap smears that require colposcopic evaluations as defined by the fourth American Society of Colposcopy and Cervical Pathology (ASCCP) sponsored guidelines for management of cervical cancer abnormalities during the next 6 months are excluded. Subjects with abnormal pap smear and who have undergone colposcopic evaluation which has determined that a cervical procedure is not necessary during the 6 months following the colposcopy are allowed.
•5\.Breast cancer or other estrogen\- or progestin\-sensitive cancer, now or in the past.
•6\.History of thrombophlebitis, venous or arterial thromboembolic diseases.
•7\.Any known severe neurological, gastrointestinal, hepatic or other disease that might interfere with the intake of an investigational drug or any study condition.
•8\.Planned surgical procedures during the study period.
•9\.Clinically relevant/significant findings from serum biochemistry and hematology and HBsAg and C Virus/HlV serology as evaluated by the investigator.
•10\.Clinically relevant electrocardiogram findings.

Sponsor

upin Research Inc