What is the mechanism of action of this treatment?

Common treatments for bleeding, particularly those similar to the DPV-LNG vaginal ring, involve mechanisms that address both contraception and infection prevention. Dapivirine, an antiretroviral, inhibits the reverse transcriptase enzyme, preventing HIV replication. Levonorgestrel, a hormonal contraceptive, prevents ovulation and thickens cervical mucus, hindering sperm entry into the uterus. These mechanisms are vital for patients as they ensure effective contraception while also providing protection against HIV, thereby addressing dual health concerns.

What side effects are associated with this type of intervention?

Levonorgestrel, a hormonal contraceptive, can cause side effects such as menstrual irregularities, headaches, nausea, breast tenderness, and mood changes. Dapivirine, an antiretroviral, is generally well-tolerated but may cause mild side effects like headache, vaginal discharge, and discomfort. Combining these agents in a vaginal ring aims to minimize systemic side effects while providing localized treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for bleeding that involve hormonal contraceptives and antifibrinolytics. Levonorgestrel, a hormonal contraceptive, is used in intrauterine devices (IUDs) like Mirena for managing heavy menstrual bleeding. Additionally, tranexamic acid, an antifibrinolytic, is approved for treating heavy menstrual bleeding. These treatments help manage bleeding by stabilizing blood clots and regulating menstrual cycles.

What other types of research exist?

Promising alternatives to the DPV-LNG vaginal ring for bleeding patients include: 1) Estradiol valerate/dienogest combination, which has shown efficacy in managing heavy menstrual bleeding. 2) Levonorgestrel-releasing intrauterine device (LNG-IUD), effective for both contraception and reducing menstrual bleeding. 3) Gonadotropin-releasing hormone (GnRH) analogues, which can manage endometriosis-related bleeding and pain. Patients should discuss these options with their healthcare provider to determine the best treatment plan.

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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

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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days (3 cycles, one cycle is approximately 30 days of continuous use)

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)

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bleeding, particularly those similar to the DPV-LNG vaginal ring, involve mechanisms that address both contraception and infection prevention. Dapivirine, an antiretroviral, inhibits the reverse transcriptase enzyme, preventing HIV replication. Levonorgestrel, a hormonal contraceptive, prevents ovulation and thickens cervical mucus, hindering sperm entry into the uterus. These mechanisms are vital for patients as they ensure effective contraception while also providing protection against HIV, thereby addressing dual health concerns.

Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.