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
Overview
- Phase
- Phase 2
- Intervention
- LSP-5415
- Conditions
- Pregnancy Prevention
- Sponsor
- Lupin Research Inc
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Proportion of subjects in Cohort #1 with complete ovarian inhibition over 3 treatment cycles
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the inhibition of ovulation in Cohort #1 (Body Mass Index of ≥ 18 kg/m2 to ≤ 30 kg/m2) after contraceptive vaginal ring LSP-5415 application for 3 treatment cycles.
Detailed Description
This is an open-label study to evaluate inhibition of ovulation during treatment with LSP-5415 over a period of 3 treatment cycles (approximately 3 months) in healthy female volunteers with a documented ovulatory cycle (pre-treatment cycle). The study will consist of two subject cohorts; Cohort #1 will consist of a total of 16 healthy women aged 18-35 years with a BMI of ≥ 18 kg/m2 to ≤ 30 kg/m2, Cohort #2 will consist of up to 10 healthy women aged 18-35 years with a BMI of \> 30 kg/m2 to ≤ 35 kg/m2. The study will consist of 3 treatment cycles each consisting of a 26 day ring-insertion period followed by a 2-day ring-free period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be able to read and write and willing to sign Informed Consent Form prior to study participation in accordance with legal requirements.
- •Females (18 to 35 years of age, inclusive) without uncontrolled concomitant disease at the Baseline Visit.
- •Have a regular menstrual cycle that is 24-32 days in duration.
- •Cohort #1 - BMI of 18 kg/m2 to 30 kg/m2, inclusive. Cohort #2 - BMI \> 30 kg/m2 to ≤ 35 kg/m
- •Will not be at risk for pregnancy; subjects must agree to consistently use reliable non-hormonal contraceptive methods (spermicide-coated condoms, sterilization, male partner'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.
- •Both ovaries and uterus must be intact, and visible on transvaginal ultrasound (TVUS) examination during screening.
- •Subjects must be in good physical and mental health as determined by vital signs, medical history and clinical examination.
- •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.
- •Be at least 3 months after a delivery or abortion.
- •Be at least six months since last progestin injection with one or more spontaneous menses.
Exclusion Criteria
- •Pregnancy, a positive serum β-hCG pregnancy test at screening or lactation.
- •Use of tobacco- or nicotine-containing products (e.g., cigarette, pipe, cigar, chewing, nicotine patch, or nicotine gum) within 6 months prior to study drug administration on Day 1 of treatment cycle
- •Have a history of cervical carcinoma or other carcinomas of the vagina or vulva.
- •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.
- •Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
- •History of thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction).
- •Any known severe neurological, gastrointestinal, hepatic (liver tumors, benign or malignant or liver disease) or other disease that might interfere with the intake of an investigational drug or any study condition.
- •Planned surgical procedures during the study period.
- •Clinically relevant/significant findings from serum biochemistry and hematology and HBsAg and C Virus/HlV serology as evaluated by the investigator.
- •Clinically relevant electrocardiogram (ECG) findings.
Arms & Interventions
LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)
LSP-5415
Intervention: LSP-5415
Outcomes
Primary Outcomes
Proportion of subjects in Cohort #1 with complete ovarian inhibition over 3 treatment cycles
Time Frame: 3 months
The primary endpoint is the proportion of subjects in Cohort #1 with complete ovarian inhibition over the entire treatment period (3 treatment cycles). Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score (Hoogland HJ, Skouby SO, 1993). This score is based on: * The follicular size assessed by transvaginal ultrasound (TVUS). * Endogenous hormone levels: serum Estradiol (E2), and serum Progesterone (P). A Hoogland and Skouby grade 3 and below represents ovulation inhibition
Secondary Outcomes
- Safety (Number of study subjects with treatment-emergent adverse events)(3 months)
- Measurement of Samples for sex hormone-binding globulin (SHBG)(3 months)
- Measurement of Serum level of Luteinizing Hormone (LH)(3 months)
- Measurement of Plasma level of Ethinyl Estradiol (EE), Etonogestrel (ENG)(3 months)