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Antiretroviral

Dapivirine + Levonorgestrel Vaginal Rings for Bleeding, Pharmacokinetics, and Safety Concerns

Phase 1 & 2
Recruiting
Research Sponsored by International Partnership for Microbicides, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Consistent and correct male condom use*
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days (3 cycles, one cycle is approximately 30 days of continuous use)
Awards & highlights

Study Summary

This trial is testing two different formulations of a vaginal ring for their pharmacokinetics, or how the body processes the drug. The trial is double-blind, meaning that neither the participants nor the researchers know who is receiving which formulation.

Who is the study for?
This trial is for individuals assigned female at birth, aged 18-45, who are in good health and not currently pregnant or breastfeeding. Participants must have regular menstrual cycles, be HIV-negative with an intact uterus and at least one ovary, and agree to avoid certain medications that interact with the study drugs. They should not use hormonal contraceptives recently or have a history of significant allergies to the study products.Check my eligibility
What is being tested?
The trial is testing two different vaginal ring formulations containing Dapivirine and Levonorgestrel (IPM Ring-105 and IPM Ring-106) over a period of 90 days. It's designed to measure how these rings affect local tissues as well as their overall safety when used consistently.See study design
What are the potential side effects?
Potential side effects may include local irritation or discomfort where the ring is inserted, changes in menstrual bleeding patterns, possible increased risk of infections like UTIs or RTIs due to alterations in vaginal flora, and systemic effects related to levonorgestrel such as headaches or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You consistently and correctly use male condoms during sexual activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days (3 cycles, one cycle is approximately 30 days of continuous use)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days (3 cycles, one cycle is approximately 30 days of continuous use) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in cervicovaginal fluid
Evaluate pharmacokinetics by assessing changes in baseline of DPV and LNG concentrations in plasma
Secondary outcome measures
Assessing vaginal bleeding patterns associated with the two DPV-LNG vaginal ring formulations
Duration of study vaginal ring removal
Frequency of study vaginal ring removal (voluntary and involuntary)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IPM Ring-105Experimental Treatment1 Intervention
Ring-105 (xx mg dapivirine + xxx mg levonorgestrel)
Group II: IPM Ring-106.Active Control1 Intervention
Ring-106 (xx mg dapivirine + xxx mg levonorgestrel)

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,548 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,962 Previous Clinical Trials
2,674,689 Total Patients Enrolled
International Partnership for Microbicides, Inc.Lead Sponsor
45 Previous Clinical Trials
9,550 Total Patients Enrolled

Media Library

IPM Ring-105 (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT05041699 — Phase 1 & 2
Bleeding Research Study Groups: IPM Ring-105, IPM Ring-106.
Bleeding Clinical Trial 2023: IPM Ring-105 Highlights & Side Effects. Trial Name: NCT05041699 — Phase 1 & 2
IPM Ring-105 (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041699 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this research encompass individuals of advanced age?

"This trial is restricted to individuals between 18 and 45 years of age. Separately, there are 65 studies for minors and 359 studies targeting elderly citizens."

Answered by AI

Are there any open slots available for this research trial?

"According to clinicaltrials.gov, the enrollment period for this trial has closed since June 21st 2022; however there are still 447 other medical studies actively seeking patients. The study was initially posted on June 1st of 2022."

Answered by AI

What are the prerequisites for participating in this experiment?

"This medical research is seeking 40 individuals aged between 18 and 45, who are displaying symptoms of haemorrhage. These potential participants must also meet the following criteria: female assigned gender at birth (exception given to those on a female-male transition therapy in last 90 days), abstention from any vaginal insertion/intercourse for day prior to enrollment visit, contact information provided; availability for all visits adhering with study procedures and requirements, non-hormonal intrauterine device inserted over 3 months ago."

Answered by AI
~6 spots leftby Aug 2024