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Pregnancy PreventionPhase 2NCT05360550

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

A Phase 2 study testing LSP-5415 in people with Pregnancy Prevention, run by Lupin Research Inc at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Prevention
What is being tested?
LSP-5415
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteIndia
Study dates
5 Jul 2022to 12 Jan 2023
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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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 -
  • 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, anticardiolipin 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 after use of long-acting injectable contraceptive therapy (depo-medroxyprogesterone) or implant hormonal therapy prior to the pre-treatment cycle.
  • Use of hormonal or non-hormonal Intrauterine devices (IUDs) within 30 days prior to the start of the pre-treatment cycle.
  • Participation in another clinical trial at same time or within the preceding three months.
  • Subjects with a desire to become pregnant during the study.
  • Undiagnosed vaginal discharge, 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 one cycle prior to the start of the pre-treatment cycle until the end of treatment cycles (except 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.
  • any Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Site 01

    Mohope, Mumbai, 40710

Other trials in India

About this study

Official title: 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

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.

Read the 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.

Being tested
LSP-5415

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LSP-5415Drug

    pregnancy prevention

Study groups in NCT05360550
Study groupRoleWhat they receive
LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring)ExperimentalLSP-5415
Receives: Drug: LSP-5415

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (4)

  1. Measurement of Serum level of Luteinizing Hormone (LH)

    Serum level of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), E2, P

    Measured: 3 months

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

    Plasma level of Ethinyl Estradiol (EE), Etonogestrel (ENG): Blood samples will be taken at regular time points during Cycle 3 (26-day wear period).

    Measured: 3 months

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

    Samples for sex hormone-binding globulin (SHBG) will be collected preinsertion on Cycle 1, Day 1 and pre-removal on Cycle 3, Day 27.

    Measured: 3 months

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

    To assess the safety of LSP-5415 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.

  1. First posted4 May 2022
  2. Study start5 Jul 2022
  3. Primary completion12 Jan 2023
  4. Study completion12 Jan 2023

Resources

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
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360550
Sponsor's protocol ID
CVR-WH-202
Status last verified
Mar 2023
First submitted
21 Jan 2022
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LSP-5415 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 11 inclusion and 37 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 9 Mar 2023. 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?

Proportion of subjects in Cohort #1 with complete ovarian inhibition over 3 treatment cycles (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05360550.

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 9 Mar 2023.

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