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A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets (Drug); norelgestrominum and ethinylestradiol patch oral contraceptive patch (Drug); Nuvaring â„¢ (etonorgestrel/ethinylestradiol) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30).

Clinical Details

Official title: An Open-label, Randomized, Parallel Group Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group

Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group

AUC 0-tlast (PK Parameter) for the ASPE Group.

AUC 0-infinity (PK Parameter) for the ASPE Group.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Subject is at least 18 but not older than 40 years of age on Day 1 of treatment.

- Subject has uterus and ovaria in situ

- Subject who does not use hormonal contraception and is willing to use adequate

nonhormonal contraceptive measures during the timeframe between screening and start treatment.

- Subject is able and willing to refrain from caffeine and/or xanthine containing food

and/or beverages (e. g. coffee, tea, cola or chocolate) from 24 hours before the first administration of the trial medication until the last PK blood sample.

- Subject is willing not to consume grapefruit containing products 14 days prior to the

start of the first administration of the trial medication until the last PK blood sample.

- Subject is willing to refrain from smoking from 7 days prior to first administration

of the trial medication until the last pharmacokinetic blood sample.

- Subject is willing to refrain from alcohol containing products from 24 hours prior to

first administration of the trial medication until the last pharmacokinetic blood sample. Exclusion Criteria:

- Contraindications for use of NuvaRing, contraceptive patch and oral contraceptive:

- Presence or history of venous thrombosis, with or without the involvement of

pulmonary embolism.

- Presence or history of arterial thrombosis (e. g. cerebrovascular accident, myocardial

infarction) or prodromi of a thrombosis (e. g. angina pectoris or transient ischaemic attack).

- Known predisposition for venous or arterial thrombosis, with or without hereditary

involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) and Factor V Leiden mutation.

- 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

- Presence or history of severe hepatic disease as long as liver function values had

not returned to normal or were judged to be clinically significant by the investigator.

- Presence or history of liver tumours (benign or malignant).

- Known or suspected malignant conditions of the genital organs or the breasts, if

sex-steroid-influenced.

- Undiagnosed vaginal bleeding.

- Hypersensitivity to the active substances or to any of the excipients of NuvaRing,

contraceptive patch and oral contraceptive.

- Migraine with focal aura

- Known or suspected pregnancy

- Breastfeeding, or within 2 months after stopping breastfeeding on the day preceding

the first administration of trial medication (Day - 1).

- Clinically significant abnormal laboratory, ECG (electrocardiogram) vital signs,

physical and gynecological findings at screening.

- A significant (history of) allergic or other serious disease, particularly

gastrointestinal tract disease.

- Smoking more than 5 cigarettes or 1 pipe or 1 cigar per day for a period of at least

3 months prior to screening.

- Using any systemic medication (including over the counter (OTC) medication) during

the 14 days prior to the day preceding the first administration of trial medication

(Day - 1), except for oral contraceptive used for synchronization and occasional

Ibuprofen.

- Used any drug or substance that is known to induce drug-metabolizing enzymes within

two months prior to the start of synchronization.

- Received a contraceptive by injection, an implant or hormonal intra-uterine device

within 6 months of the day preceding the first administration of trial medication

(Day - 1), or a hormonal implant or hormonal intra-uterine device removed within 6

months of the day preceding the first administration of trial medication (Day - 1).

- Participated in a drug trial and was administered an investigational drug during the

90 days prior to start of synchronization.

- Donated blood during the 90 days prior to the day preceding the first administration

of trial medication (Day - 1).

- History (within the last 2 years) of excessive alcohol use, use of solvents or of

drug abuse.

- Positive drug test at screening and/or admission (Day -1), or a positive alcohol test

at admission (Day - 1).

- Clinically significant abnormal cervical smear result (papaninecolaou (PAP) III or

higher) at screening.

- Acute or chronic hepatitis B/C or human immune deficiency virus (HIV) 1&2 infection.

Locations and Contacts

Additional Information

Starting date: March 2004
Last updated: June 4, 2015

Page last updated: August 23, 2015

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