An Open-label, Randomized, 2-Period, Crossover, Pharmacokinetics Study

NCT05360576 | Completed Phase 2 FDA Drug

• 1 other identifier: CVR-WH-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females

Conditions

Pregnancy Prevention

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics (Cmax)

  To assess the pharmacokinetics (PK) (Cmax) of etonogestrel (ENG) and ethinyl estradiol (EE) following LSP-5415 (28 days) and NuvaRing (28 days) administration.

  28 Days

• Pharmacokinetics (Tmax)

  To assess the pharmacokinetics (PK) (Tmax) of etonogestrel (ENG) and ethinyl estradiol (EE) following LSP-5415 (28 days) and NuvaRing (28 days) administration.

  28 Days

• Pharmacokinetics (AUC)

  To assess the pharmacokinetics (PK) (AUC) of etonogestrel (ENG) and ethinyl estradiol (EE) following LSP-5415 (28 days) and NuvaRing (28 days) administration.

  28 Days

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

  To assess the safety of LSP-5415 and NuvaRing in healthy adult female subjects.

  3 months

Study Arms (2)

LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)

EXPERIMENTAL

Test Product

Drug: LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring); Drug: NuvaRing Vaginal Ring

NuvaRing® (etonogestrel/ethinyl estradiol 11.7/2.7 mg)

ACTIVE COMPARATOR

Reference Product

Drug: LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring); Drug: NuvaRing Vaginal Ring

Interventions

LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring) DRUG

To prevent pregnancy

Also known as: LSP-5415

LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring); NuvaRing® (etonogestrel/ethinyl estradiol 11.7/2.7 mg)

NuvaRing Vaginal Ring DRUG

To prevent pregnancy

Also known as: NuvaRing

LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring); NuvaRing® (etonogestrel/ethinyl estradiol 11.7/2.7 mg)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: females of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be able, and willing, to sign Informed Consent Form prior to study participation in accordance with legal requirements.
• Females (18 to 40 years of age, inclusive) without uncontrolled concomitant disease at Baseline Visit.
• Have a regular menstrual cycle that is 24-32 days in duration.
• Body Mass Index (BMI) of 18 kg/m2 to 30 kg/m2.
• Will not be at risk for pregnancy, subjects must agree to consistently use reliable non-hormonal contraceptive methods (spermicide-coated condoms, 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. -
• Subjects must be in good physical and mental health as determined by vital signs, medical history.
• 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.
• 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 ß-hCG pregnancy test at screening or lactation.
• Use of tobacco- or nicotine-containing products (e.g., cigarette, pipe, cigar, chewing, vaping, nicotine patch, or nicotine gum) within 6 months prior to check-in on Day -1.
• Have a history of cervical carcinoma or other carcinomas of the vagina or vulva.
• Have a history of breast cancer or any hormonally sensitive cancer.
• 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 until they have undergone colposcopic evaluation which has determined that a cervical procedure is not necessary during the 6 months following the colposcopy.
• History of thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction).
• Any known severe neurological, gastrointestinal, hepatic or other disease that might interfere with the intake of an investigational drug or any study condition.
• Clinically relevant findings from serum biochemistry and hematology and HBsAg and C Virus/HlV serology as evaluated by the investigator.
• Clinically relevant/significant electrocardiogram (ECG) findings.
• 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
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
• Have inherited or acquired hypercoagulopathies
• Have uncontrolled hypertension

Sponsors & Collaborators

• Lupin Research Inc: lead

Study Sites (1)

Site 01

Mohope, Mumbai, 40710, India

Location

MeSH Terms

Interventions

etonogestrel; NuvaRing

Study Design

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

Model Details: All subjects will receive LSP-5415 (28 days) and NuvaRing (28 days) under fasted conditions. There will be a 28-day washout period after ring removal in Treatment Period 1 and ring insertion in Treatment Period 2.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: May 4, 2022
• Study Start: February 24, 2022
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)