Hormonal contraception and primary dysmenorrhea in woman seeking contraception. MedDRA version: 19.0 Level: LLT Classification code 10073728 Term: Hormonal contraception System Organ Class: 100000004865
Conditions
Interventions
Product Name: Etonogestrel/Estradiol
Product Code: MK-8342B
Pharmaceutical Form: Vaginal delivery system
INN or Proposed INN: Etonogestrel
CAS Number: 54048-10-1
Current Sponsor code: MK-8342
Other d
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy female either postmenarcheal adolescents =12 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study 2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator 3. History of any illness that, in the Investigator's opinion, might confound the results of the study or poses an additional risk to the subject by their participation in the study 4. History or presence of alcoholism or drug abuse within the past 2 years, prior to vaginal ring insertion 5. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds 6. History or presence of: venous thromboembolic events (VTE), arterial thromboembolic events (ATE), and other major adverse cardiovascular events (MACE) (e.g., myocardial infarction, cerebral vascular accident); migraines or severe headaches; breast cancer or undiagnosed breast nodules; hypertension; transient ischemic attacks; liver tumors or liver disease; jaundice with previous use of oral contraceptives or past pregnancy; diabetes; pancreatitis or severe hypertriglyceridemia; carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia; family history of 1st degree relative with breast or ovarian cancer; cervical cancer, or cervical procedures including loop electrosurgical excision procedure or conization (i.e., cold knife cone biopsy from the mucous membrane of the cervix); any condition that would contraindicate the use of hormonal contraceptives 7. Positive pregnancy test or lactating 8. Abnormal cervical Pap test within 1 year prior to screening. 9. Within the past 6 months of first vaginal ring insertion, has had undiagnosed (unexplained) abnormal vaginal bleeding or any abnormal bleeding that is expected to recur during the study (e.g., bleeding from cervical polyp, bleeding after sex). 10. Has stage 4 pelvic organ prolapse (1 cm beyond introitus) or lesser degrees of prolapse with a history of difficulty retaining tampons, vaginal rings, or other products within the vagina 11. Clinically significant abnormalities of the genital organs as determined by a gynecologist and based on the Investigator’s judgment 12. Has gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis. Subjects may be rescreened 3 weeks after completing treatment for these conditions 13. Positive results for the urine drug and/or alcohol screen at screening or each check in 14. Drink alcohol in excess of 14 glasses/units per week (1 unit = 125 mL of wine or 284 mL of beer or 25 mL of 45% alcohol) 15. Positive urine cotinine at screening (threshold >10 ng/mL). Note: subjects may be retested at screening if positive. 16. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) 17. Unable to refrain from or anticipates the use of: • Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first vaginal ring cycle and throughout the study. Paracetamol (up to 2 g per 24 hours) may be permitted for minor ailments (e.g., in case of menstrual pain, sunburn, fever). • Any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John’s wort, for 28 days prior to the first vaginal ring cycle and throughout the study. Appropriate sources will be consulted by the Investigator or d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective 1: To investigate the pharmacokinetics of ENG, E2 and E1 (estrone) following administration of MK-8342B (ENG-E2, 125/300 µg/day) vaginal ring in healthy female postmenarcheal adolescents (=12 to <18 years of age) and in healthy female adults (=18 to =36 years of age). Objective 2: To evaluate the pharmacodynamic effects (on progesterone [P], luteinizing hormone [LH], follicle-stimulating hormone [FSH], and Sex hormonal binding globulin [SHBG] following administration of MK-8342B (ENG-E2, 125/300 µg/day) vaginal ring in healthy female postmenarcheal adolescents (=12 to <18 years of age) and in healthy female adults (=18 to =36 years of age). Objective 3: To investigate the safety and tolerability following administration of MK-8342B (ENG-E2, 125/300 µg/day) vaginal ring in healthy female postmenarcheal adolescents (=12 to <18 years of age) and in healthy female adults (=18 to =36 years of age).;Secondary Objective: Not applicable;Primary end point(s): 1. Pharmacokinetic: • Tmax - Time to maximum observed serum drug concentration • Cmax - Maximum observed serum concentration • AUC1-29 - Area under the concentration versus time curve, from Day 1 (0 hour) to Day 29 (672 hours) after vaginal ring insertion • AUC1-22 - Area under the concentration versus time curve, from Day 1 (0 hour) to Day 22 (504 hours) after vaginal ring insertion • Cmin - Minimum observed/measured non-zero concentration • Cavg1-29 - Ratio of AUC1-29 to the corresponding time interval (Day 1 [0 hour] to Day 29 [672 hours after vaginal ring insertion]) • Cavg1-22 - Ratio of AUC1-22 to the corresponding time interval (Day 1 [0 hour] to Day 22 [504 hours after vaginal ring insertion]) • apparent t1/2 - Apparent terminal half life for ENG, E2, and E1 in Cycle 2 in serum, as appropriate. 2. Pharmacodynamic: Raw and percent change from baseline (Hour 0 of cycle 2) values for serum hormone concentrations for P, LH, FSH, and SHBG will be presented at each time point. Summary stati | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Austria
Contacts
Public ContactProject Management and Monitoring
Assign Clinical Research GmbH
Outcome results
None listed