Vaginal ring dose-finding study on ovarian function and vaginal bleeding in healthy women aged 18-35 years

Active, not recruiting

• Conditions: This is the dose-finding study on ovarian function, vaginal bleeding pattern, and pharmacokinetics associated with the use of combined vaginal rings in healthy women; MedDRA version: 14.1Level: LLTClassification code 10046883Term: Vaginal bleedingSystem Organ Class: 100000004872; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-002459-41-DK
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-19
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 680

Inclusion Criteria

1. Subject must be willing and able to provide written informed consent for the trial.
2. Subject must be female.
3. Subject must be =18 to = 35 years of age.
4. Subject must have a body mass index (BMI) =18 and =35.
5. Subject must have regular cycles from 24 to 35 days in length, with an intraindividual variation of ±3 days permitted.
6. Each non-sterilized sexually active subject of child-bearing potential must agree to use condoms for contraception during the screening period, treatment period, and post-treatment period until the final study visit (see Section 7.4.1.3.2 for more details).
7. Subject using a hormonal contraceptive (combined or progestin-only), or a nonhormonal IUD, at the screening visit must agree to stop using that method.
8. Subject must be in good physical and mental health, based upon the medical judgment of the investigator.
9. Subject must be able to adhere to dose and visit schedules, and does not plan to relocate during the study.
10.To participate in the pharmacogenetic analysis, the subject must be willing to give written informed consent for the pharmacogenetic testing and able to adhere to the study’s dose and visit schedules. NOTE: A subject unwilling to sign the informed consent for pharmacogenetic testing may be included in the trial; however, pharmacogenetic samples must not be obtained.
11.Subject continues to meet all of the inclusion criteria completed at the screening visit.
12.Subject is not pregnant. At the randomization visit, the subject has had a negative urine pregnancy test at Visit 2 in the clinic prior to being randomized.
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 680
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has any of the following contraindications to the use of contraceptive
steroids:
- Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis,
pulmonary embolism, myocardial infarction) or of a cerebrovascular accident;
- Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris);
- History of migraine with focal neurological symptoms;
- Diabetes mellitus with vascular involvement;
- The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the (sub)-investigator).
e.g. increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age); obesity (body mass index over 30 kg/m2); migraine, valvular heart disease, atrial fibrillation; prolonged immobilization, major surgery, any surgery to the legs, or major trauma (in these situations it is advisable to discontinue the COC use and not to resume until two weeks after full remobilization); systemic lupus erythematosus; haemolytic uraemic syndrome; chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis); sickle cell disease;
- Severe dyslipoproteinemia
- Severe hypertension
- Hereditary or acquired predisposition for venous or arterial thrombosis, such as known APC resistance, known antithrombin-IIIdeficiency, known protein C deficiency, known protein S deficiency, known hyperhomocysteinaemia and known antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
- Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia;
- Presence or history of severe hepatic disease as long as liver function values have not returned to normal;
- Presence or history of liver tumors (benign or malignant);
- Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts);
- Undiagnosed vaginal bleeding;
- Known or suspected pregnancy;
- Hypersensitivity to the active substances or to any of the excipients of the investigational product.
2. The subject has not had spontaneous menstruation following a delivery or abortion at the screening visit.
3. The subject is breastfeeding or has not had spontaneous menstruation following completion of breastfeeding at the screening visit.
4. The subject has participated in an investigational drug study within the past 30 days prior to the screening visit.
5. Subject has a history of malignancy =5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
6. The subject had a documented abnormal cervical smear result within 6 months prior to the screening visit
7. The subject is a user of recreational or illicit drugs, or has had any recent history of drug abuse.
8. Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking. NOTE: (1) One alcoholic drink is defined as 5 oz (150 mL) of wine, or 12 oz (350 mL) of beer, or 1.5 oz (50 mL) of 80-proof liquor. NOTE: (2) Binge drinking is defined as a pattern of 5 or more alcoholic drinks (male), or 4 or more alcoholic drinks (female) in about 2 hours.
9. The subject has an allergy/sensitivity to the investigational products or their exci

Study & Design

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