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

NCT05360550 | Completed Phase 2 FDA Drug

• 1 other identifier: CVR-WH-202
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects in Cohort #1 with complete ovarian inhibition over 3 treatment cycles

  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

  3 months

Secondary Outcomes (4)

• Measurement of Serum level of Luteinizing Hormone (LH)

  3 months

• Measurement of Plasma level of Ethinyl Estradiol (EE), Etonogestrel (ENG)

  3 months

• Measurement of Samples for sex hormone-binding globulin (SHBG)

  3 months

• Safety (Number of study subjects with treatment-emergent adverse events)

  3 months

Study Arms (1)

LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)

EXPERIMENTAL

LSP-5415

Drug: LSP-5415

Interventions

LSP-5415 DRUG

pregnancy prevention

LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Healthy Adult Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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/m2. -
• 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.
• Willing to abstain from vaginal products e.g., tampons, intravaginal medications etc. during the ring wear period for the study duration except water based vaginal lubricants/spermicides.

You may not qualify if:

• 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 1.
• 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.
• Anovulatory pre-treatment cycle, or no ovulation by Day 27 of the pretreatment cycle, or sonographical peculiarities concerning the ovarian status (e.g., ovarian cyst formation), that have not disappeared during the pretreatment cycle.
• Ovarian cyst larger than 3 cm in largest dimension on TVUS that persists during the pre-treatment ovulatory cycle.
• Additional contraindications related to the use of ethinyl estradiol (EE), or hormonal contraceptives including women with a high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
• Have cerebrovascular disease
• Have coronary artery disease -

Sponsors & Collaborators

• Lupin Research Inc: lead

Study Sites (1)

Site 01

Mohope, Mumbai, 40710, India

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: May 4, 2022
• Study Start: July 5, 2022
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

IN (1)