Overview

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

Status:
Terminated
Trial end date:
2016-09-12
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study was to evaluate the efficacy of the etonogestrel (ENG) + 17β-estradiol (E2) (MK-8342B) vaginal ring compared to placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. This study was also to 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Desogestrel
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Etonogestrel
Ibuprofen
Polyestradiol phosphate
Criteria
Inclusion Criteria:

- Post-menarcheal female, age ≤50 years, in good physical and mental health.

- History of moderate to severe primary dysmenorrhea for the past 3 months or longer,
and no history of recurrent non-menstrual pelvic pain intermittently or continuously
throughout the month, and no history of dysmenorrhea secondary to structural pelvic
pathology.

- Body mass index (BMI) of ≥18 and <38 kg/m^2.

- History of regular menstrual cycles with a cycle length between 24 and 32 days
(inclusive) for the past three months.

- Willing to adhere to use of the vaginal ring and to all required trial procedures, and
not planning to relocate during the study.

- Willing to use the rescue medication ibuprofen at the study recommended dose and no
other pain medication for treatment of dysmenorrhea.

Exclusion Criteria:

- Cardiovascular risks and disorders, including history of venous thromboembolic [VTE]
events, arterial thrombotic or thromboembolic [ATE] events, transient ischemic attack,
angina pectoris, or claudication; at higher risk of VTE events due to recent prolonged
immobilization, plans for surgery requiring prolonged immobilization, or a hereditary
or acquired predisposition or elevated risk for venous or arterial thrombosis;
currently smoking or uses tobacco/nicotine containing products and is ≥35 years of
age; uncontrolled or severe hypertension; history of severe dyslipoproteinemia; <35
years of age with a history of migraine with aura or focal neurological symptoms or
≥35 years of age with a history of migraines with or without aura or focal neurologic
symptoms; diabetes mellitus with end-organ involvement or >20 years duration; multiple
cardiovascular risk factors such as ≥35 years of age, obesity, inadequately controlled
hypertension, use of tobacco/ nicotine products, or inadequately controlled diabetes.

- Gynecologic conditions: surgically sterilized, has used hormonal contraceptives (pill,
patch, ring, implant, intrauterine system) within the past 3 months, or currently uses
non-hormonal intrauterine device (IUD); within past 6 months has had undiagnosed
(unexplained) abnormal vaginal bleeding or any abnormal vaginal bleeding expected to
recur during study; has gonorrhea, chlamydia, or trichomonas or symptomatic
vaginitis/cervicitis; has abnormal cervical smear or positive high-risk human
papillomavirus (HPV) test at screening or documented within 3 years of screening; has
Stage 4 pelvic organ prolapse (1 cm beyond introitus) or lesser degrees of prolapse
with history of difficulty retaining tampons, vaginal rings, or other products within
vagina.

- Gastrointestinal and urologic disorders, including history of pancreatitis associated
with severe hypertriglyceridemia; clinically significant liver disease, including
active viral hepatitis or cirrhosis; or a history of the gastrointestinal or urologic
tract which may cause pelvic pain.

- Other medical disorders, including history of malignancy ≤5 years prior to signing
informed consent except for adequately treated basal cell or squamous cell skin cancer
or in situ cervical cancer; any disease that may worsen under hormonal treatment such
as disturbances in bile flow, systemic lupus erythematosus, pemphigoid gestationis or
idiopathic icterus during previous pregnancy, middle-ear deafness, Sydenham chorea, or
porphyria; known allergy/sensitivity or contraindication to the investigational
products or their excipients; known allergy/sensitivity or contraindication to
ibuprofen, or has experienced asthma, urticaria, or allergic-type reactions after
taking aspirin, or other nonsteroidal anti-inflammatory drugs; history of drug or
alcohol abuse or dependence.

- Known or suspected pregnancy, or had been pregnant or breastfeeding within past 2
months.

- Has used investigational drug and/or participated in other clinical trial within past
8 weeks.