Pregnancy PreventionPhase 2NCT05360576
An Open-label, Randomized, 2-Period, Crossover, Pharmacokinetics Study
A Phase 2 study testing LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring) and NuvaRing Vaginal Ring in people with Pregnancy Prevention, run by Lupin Research Inc at 1 site in India.
Trial summary
An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Prevention
- What is being tested?
- LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring) and NuvaRing Vaginal Ring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 24 Feb 2022to 4 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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
- Have diabetes mellitus with vascular disease
- Have headaches with focal neurological symptoms or migraine headaches with aura
- History of migraine with focal neurological symptoms.
- Known hereditary or acquired predisposition for venous and/or arterial thromboembolism (e.g., activated protein C [APC] resistance, anti-cardiolipin antibodies).
- Less than 2 weeks remobilization after major surgery or prolonged immobilization
- Alcohol, drug, or medicine abuse, or suspicion thereof.
- Known allergy to any ingredient of the investigational drug.
- Use of long-acting injectable or implant hormonal therapy. A washout period of 10 months and two regular cycles is required for long-acting injectable contraceptive therapy or implant hormonal therapy (e.g., depo-medroxyprogesterone) prior to the start of screening.
- Use of hormonal or non-hormonal IUDs within 30 days prior to the start of screening.
- Participation in another clinical trial at same time or within the preceding three months
- Not fulfilling study specific requirements at screening.
- Subjects desire to become pregnant during the Study.
- Undiagnosed vaginal discharge/bleeding, vaginal lesions/ abnormalities or undiagnosed abnormal uterine bleeding. Subjects suspected of having a vaginal infection (e.g., chlamydia, gonococcus, yeast, trichomoniasis, or bacterial vaginosis, etc.) may be enrolled after treatment and subsequent negative test results; partner treatment is also recommended (as per treatment guidelines).
- Regular intake or use of the following medication:
- any drugs that might interfere with the investigational drug.
- any hormonal preparation 30 days prior to the start of screening (except for treatment for thyroid disorders under control).
- any drugs known to induce liver enzymes (e.g., rifampicin, dexamethasone, barbiturates, anticonvulsants, St. John's Wort).
- any drugs known to inhibit CYP 3A4 (e.g. ketoconazole, verapamil, cimetidine, macrolides).
- any broad-spectrum antibiotics.
- use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT evevations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females
An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females
Read the detailed description
This is an open-label, randomized-sequence, two-period, single-center, crossover, pharmacokinetic study in 40 healthy adult female subjects (18- 40 years). 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.
- Conditions
- Pregnancy Prevention
- Being tested
- LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring), NuvaRing Vaginal Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)Drug
Also called LSP-5415
To prevent pregnancy
NuvaRing Vaginal RingDrug
Also called NuvaRing
To prevent pregnancy
| Study group | Role | What they receive |
|---|---|---|
| LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring) | Experimental | Test Product Receives: 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 Receives: Drug: LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring); Drug: NuvaRing Vaginal Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start24 Feb 2022
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lupin Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360576
- Sponsor's protocol ID
- CVR-WH-201
- Status last verified
- Jul 2022
- First submitted
- 21 Jan 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females
- ClinicalTrials.gov ID
- NCT05360576
- Acronym / sponsor ID
- CVR-WH-201
- Conditions
- Pregnancy Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lupin Research IncIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females
Detailed description
This is an open-label, randomized-sequence, two-period, single-center, crossover, pharmacokinetic study in 40 healthy adult female subjects (18- 40 years). 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring) | Experimental | Drug: LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring), Drug: NuvaRing Vaginal RingTest Product |
| NuvaRing® (etonogestrel/ethinyl estradiol 11.7/2.7 mg) | Active comparator | Drug: LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring), Drug: NuvaRing Vaginal RingReference Product |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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. -
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)Also: LSP-5415To prevent pregnancy | Drug | LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring), NuvaRing® (etonogestrel/ethinyl estradiol 11.7/2.7 mg) |
| NuvaRing Vaginal RingAlso: NuvaRingTo prevent pregnancy | Drug | LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring), NuvaRing® (etonogestrel/ethinyl estradiol 11.7/2.7 mg) |
Primary outcome
Pharmacokinetics (Cmax)
Time frame: 28 Days
To assess the pharmacokinetics (PK) (Cmax) of etonogestrel (ENG) and ethinyl estradiol (EE) following LSP-5415 (28 days) and NuvaRing (28 days) administration.
Pharmacokinetics (Tmax)
Time frame: 28 Days
To assess the pharmacokinetics (PK) (Tmax) of etonogestrel (ENG) and ethinyl estradiol (EE) following LSP-5415 (28 days) and NuvaRing (28 days) administration.
Pharmacokinetics (AUC)
Time frame: 28 Days
To assess the pharmacokinetics (PK) (AUC) of etonogestrel (ENG) and ethinyl estradiol (EE) following LSP-5415 (28 days) and NuvaRing (28 days) administration.
Safety (Number of study subjects with treatment-emergent adverse events)
Time frame: 3 months
To assess the safety of LSP-5415 and NuvaRing in healthy adult female subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring) and NuvaRing Vaginal Ring in people with Pregnancy Prevention, run by Lupin Research Inc at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (Cmax) (time frame: 28 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.