Study to assess the efficacy and safety of a new contraceptive vaginal ring containing etonogestrel and estradiol and a marketed oral contraceptive pill containing levonorgestrel and ethinyl-estradiol.

Phase 1

• Conditions: Contraception; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2014-002208-26-PL
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-15
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 2370

Inclusion Criteria

1. Provide written informed consent for both the trial and for Future Biomedical Research
2. Be a premenopausal female >18 years old at enrollment
3. Be at risk for pregnancy (heterosexual vaginal intercourse at least once per month and not sterilized) and seeking contraception
4. Be willing to use either ENG-E2 contraceptive vaginal ring or LNG-EE COC for up to 13 treatment cycles and not intending to use any other forms of contraception (e.g. condoms, except when specified per protocol)
5. Have body mass index of >18 and <38 Kg/m2. Trial sites may exclude subjects with maximum BMI less than 38 kg/m2 based on local standard of care guidelines for the use of combined hormonal contraceptives.
6. Be in good physical and mental health, based upon the medical judgment of the investigator.
7. Be able and will to adhere to use of the ENG-E2 vaginal ring or the LNG-EE COC and to all the required trial procedures, including trial visits and use of the daily diaries and does not plan to relocate during the trial (such that the subject would not be able to continue participation at the trial site).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2370
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cardiovascular risks and disorders:
1. Has a history of venous thromboembolic events (deep vein thrombosis, pulmonary embolism) or history of arterial thrombotic or thromboembolic events or a history of arterial thrombolic events (myocardial infarction, stroke, or peripheral arterial events), or a history or transient ischemia attack or angina pectoris or claudication
2. Is at a higher risk of VTE event due to recent prolonged immobilization (within 2 weeks of screening due to trauma r other illness markedly limiting mobility), plans for surgery requiring prolonged immobilization or has a hereditary or acquired predisposition or elevated risk for venous or arterial thrombosis. Refer to protocol for complete list
3. Is currently smoking or uses tobacco products and is >35 years of age
4. Has uncontrolled or severe hypertension
5. Has a history of severe dyslipoproteinemia
6. Is >35 years of age and has a history of migraine with aura or focal neurological symptoms or is >35 years of age and has a history of migraines (with or without aura)
7. Has diabetes mellitus with end organ involvement (nephropathy, retinopathy, neuropathy or vascular involvement) or has had diabetes for > 20 years
8. Has multiple cardiovascular risk factors such as older age (>35 years), obesity, BMI >30 Kg/m2), inadequately controlled hypertension, use of tobacco/nicotine, or inadequately controlled diabetes which in the opinion of the nvestigator in the composite pose an unacceptable risk of participation

Gastrointestinal Disorders:
9. Has a history of pancreatitis associated with severe hyper triglyceridemia
10. Has clinically significant liver disease which is now inactive of successfully treated may be enrolled if liver function values (AST, ALT, total bilirubin) have been normal for the past year and are within the normal range (per central lab) at V1
11. History of malabsorptive bariatric surgery (i.e., bileopancreatic diversion or Roux-en-Y bypass). Non-malabsorptive restrictive surgery is acceptable for inclusion (i.e., Gastric banding, partial gastrectomy)

Other Medical Disorders:
12. Has history of malignancy <5years prior to signing informed consent except for treated basal or squamous cell skin cancer or in situ cervical cancer. Subjects with a history or presence of liver tumors (benign or malignant) or sex steroid-influenced malignancies (e.g., of the genital organs or the breasts) are excluded regardless of the timing.
13. Has any disease that may worsen under hormonal treatment, such as disturbances in the bile flow (presence or history of cholestasis, presence of gall stones), systemic lupus erythematosus, pemphigoid gestationis or idiopathic icterus during a previous pregnancy, middle ear deafness, Sydenham chorea, or porphyria. History of cholecystectomy does not exclude a subject.
14. Has a known allergy/sensitivity or contraindication to the investigational products (ENG-E2 vaginal ring or LNG-EE COC) or their excipients).
15. Has a history (current or within the past two years) of drug or alcohol abuse or dependence.
16. Has any clinically relevant abnormal laboratory result at screening as judged by the investigator.
17. Has a history or current evidence of any condition therapy or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial.

Recent or Current

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified