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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT02668822
• Date of registration: 26/01/2016
• Prospective Registration: Yes
• Primary sponsor: Organon and Co
• Public title: Efficacy and Safety of Etonogestrel + 17ß-Estradiol Vaginal Ring (MK-8342B) in the Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)
• Scientific title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of MK-8342B (ENG-E2 Vaginal Ring) in Women With Moderate to Severe Primary Dysmenorrhea
• Date of first enrolment: February 9, 2016
• Target sample size: 18
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02668822
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Chile, Italy, Poland, Puerto Rico, Russian Federation, South Africa, Sweden, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Dysmenorrhea

Intervention(s)

Drug: Ibuprofen

Drug: Placebo vaginal ring

Drug: ENG 125 µg + E2 300 µg vaginal ring (MK-8342B)

Primary Outcome(s)

Number of Participants Who Experienced an Adverse Event (AE) [Time Frame: Up to approximately 126 days]

Percentage of Participants With =3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline [Time Frame: Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant]

Number of Participants Who Discontinued Study Treatment Due to an AE [Time Frame: Up to approximately 112 days]

Secondary Outcome(s)

Change From Baseline in the Mean Pelvic Pain Score at Treatment Cycle 2 [Time Frame: Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant]

Percentage of Participants With =3-point Reduction in Peak Pelvic Pain Score and a Decrease in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline [Time Frame: Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant]

Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2 [Time Frame: Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant]

Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2 [Time Frame: Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant]

Percentage of Participants With Pelvic Pain Score of "0" or "1" and no Use of Ibuprofen Tablets at Treatment Cycle 2 [Time Frame: Treatment Cycle 2 4-day cramping window, as determined by committee for each participant]

Secondary ID(s)

2015-004326-34

8342B-060

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02668822