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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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring, Placebo vaginal ring, Ibuprofen
Not yet recruiting
Merck Sharp & Dohme Corp.
Published on BioPortfolio: 2016-01-31T17:27:22-0500
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...
The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the number o...
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment effic...
The purpose of this study is to assess the contraceptive efficacy of the ENG-E2 vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expr...
The purpose of the study is to assess the performance and safe use of the vaginal ring applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in healthy wome...
We assessed the interference between vaginal ring use and menses among women who participated in the qualitative component of the MTN-020/ASPIRE vaginal ring trial in Malawi, South Africa, Uganda and ...
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 ...
The primary aim was to investigate post-use ring weight as a potential measure of cumulative adherence to a progesterone-releasing 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.
The past fifteen years have witnessed a resurgence of interest in vaginal ring technologies for drug delivery applications, mostly driven by the impetus for development of vaginally-administered antir...
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.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
Pain is a feeling (sharp or dull) triggered in the nervous system which can be transient or constant. Pain can be specific to one area of the body eg back, abdomen or chest or more general all over the body eg muscles ache from the flu. Without pain ...