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Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring in Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)

2016-01-31 17:27:22 | BioPortfolio

Summary

The purpose of this study is to evaluate the efficacy of the etonogestrel (ENG) + 17β-estradiol (E2) vaginal ring compared to placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. This study will also assess the safety and tolerability of the ENG-E2 vaginal rings over 4 treatment cycles. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal ring results in a greater proportion of participants with a ≥ 3 point reduction in peak pelvic pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at Treatment Cycle 2 as compared to baseline.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Dysmenorrhea

Intervention

Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring, Placebo vaginal ring, Ibuprofen

Status

Not yet recruiting

Source

Merck Sharp & Dohme Corp.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-01-31T17:27:22-0500

Clinical Trials [1785 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)

The purpose of this study is to assess the etonogestrel (ENG) + 17β-estradiol (E2) vaginal ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at Treatment...

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A Study to Evaluate the Effect of Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)

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PubMed Articles [2965 Associated PubMed Articles listed on BioPortfolio]

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A vaginal ring containing dapivirine is effective for HIV prevention as pre-exposure prophylaxis (PrEP). We evaluated the potential epidemiological impact and cost-effectiveness of dapivirine vaginal ...

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First Impressions Matter: How Initial Worries Influence Adherence to the Dapivirine Vaginal Ring.

In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Africa, we assessed whether worries about ring use changed over time and were associated with adherence.

Development and pharmacokinetics of a combination vaginal ring for sustained release of dapivirine and the protein microbicide 5P12-RANTES.

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Medical and Biotech [MESH] Definitions

The uptake of substances from the VAGINA via the vaginal epithelium/mucosa.

Collection of pooled secretions of the posterior vaginal fornix for cytologic examination.

An incision of the posterior vaginal wall and a portion of the pudenda which enlarges the vaginal introitus to facilitate delivery and prevent lacerations.

A group of two-ring heterocyclic compounds consisting of a benzene ring fused to a diazepine ring.

Compounds based on a seven-membered ring fused to a five-membered ring. Heat can rearrange them to NAPHTHALENES which have two fused six-membered rings. They are similar to guaiazulenes which are SESQUITERPENES with a six-membered ring fused to a five-membered ring.

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