Cycle Control and Safety of E2-DRSP

NCT ID: NCT00653614

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 635 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-06-30

Brief Summary

The study will be performed as a multi-center, randomized, double-blind, parallel-group trial in fertile women aged between 18 and 35 years inclusive. A total of 600 volunteers will be randomized into one of the six treatment groups. The study will be performed only in Germany. The investigational drug is an oral contraceptive. It contains the estrogen estradiol (E2) and the progestogen drospirenone (DRSP). As the contraceptive efficacy has not yet been proven for these new regimens, even a protection against unwanted pregnancies cannot be assured. The treatments will be applied daily for 7 cycles of 28 days each without pill-free interval, i.e., for 196 consecutive days. Treatment will be initiated after a screening period of approximately 1 to 2 weeks, the latter focused on confirmation of the baseline safety status. Tablet intake will start on the first day of the first menstrual/withdrawal bleeding after Visit 2, regardless of whether the volunteer is a first user (starter) or switching from another COC. In the following cycles, tablet intake is not to be triggered by any bleeding events. The primary objective of this study is to evaluate and compare the cycle control and bleeding patterns of six different treatment regimens with E2/DRSP during administration for 7 treatment cycles. Volunteers will be provided with a diary to document the intake of study medication, any bleeding events, and days without bleeding, pregnancy test results. Safety will be also assessed. During the whole study period, 4 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breast palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.Additional examinations can be performed any time, if this becomes necessary for medical reasons. At Visit 3 or in case of premature discontinuation of study the investigator will discuss options for follow-up contraception with the volunteer. The volunteer can start the intake of a post-treatment OC on the day after the last tablet intake of study medication, after a negative urine ß-HCG test (home pregnancy test) result.

Conditions

Contraceptive, Oral, Hormonal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for one day and placebo for three days in a 28 day cycle

Group Type: EXPERIMENTAL

E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

DRSP (ZK 30595) dose 1 (SH T04984F)

Intervention Type: DRUG

Single dose administration of DRSP as a tablet

Placebo

Intervention Type: DRUG

Placebo administration in each arm

Arm 2

E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for 24 days and DRSP (ZK 30595) dose 1 (SHT04984F) for two days and placebo for two days in a 28 day cycle

Group Type: EXPERIMENTAL

E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

DRSP (ZK 30595) dose 1 (SH T04984F)

Intervention Type: DRUG

Single dose administration of DRSP as a tablet

Placebo

Intervention Type: DRUG

Placebo administration in each arm

Arm 3

E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, and placebo for days 25-28 in a 28 day cycle

Group Type: EXPERIMENTAL

E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 2 (80458739)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 3 (80458755)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

Placebo

Intervention Type: DRUG

Placebo administration in each arm

Arm 4

E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 1 (SHT04984E) for days 9-16, E2/DRSP (BAY 86-4891) dose 3 (80458755) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 1 (SHT04984F) for one day in a 28 day cycle

Group Type: EXPERIMENTAL

E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 2 (80458739)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 3 (80458755)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 4 (80458720)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

DRSP (ZK 30595) dose 1 (SH T04984F)

Intervention Type: DRUG

Single dose administration of DRSP as a tablet

Placebo

Intervention Type: DRUG

Placebo administration in each arm

Arm 5

E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891) dose 5 (80458712) for days 17-24, and placebo for 4 days in a 28 day cycle

Group Type: EXPERIMENTAL

E2/DRSP (BAY 86-4891) dose 2 (80458739)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 5 (80458712)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

Placebo

Intervention Type: DRUG

Placebo administration in each arm

Arm 6

E2/DRSP (BAY 86-4891) dose 2 (80458739) for days 1-8, E2/DRSP (BAY 86-4891) dose 4 (80458720) for days 9-16, E2/DRSP (BAY 86-4891)dose 5 (80458712) for days 17-24, placebo for 3 days, and DRSP (ZK 30595) dose 2 (80458690) for one day in a 28 day cycle

Group Type: EXPERIMENTAL

E2/DRSP (BAY 86-4891) dose 2 (80458739)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 4 (80458720)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

E2/DRSP (BAY 86-4891) dose 5 (80458712)

Intervention Type: DRUG

Single dose administration of E2 + DRSP as a tablet

DRSP (ZK 30595) dose 2 (80458690)

Intervention Type: DRUG

Single dose administration of DRSP as a tablet

Placebo

Intervention Type: DRUG

Placebo administration in each arm

Interventions

E2/DRSP (BAY 86-4891) dose 1 (SH T04984E)

Single dose administration of E2 + DRSP as a tablet

Intervention Type: DRUG

E2/DRSP (BAY 86-4891) dose 2 (80458739)

Single dose administration of E2 + DRSP as a tablet

Intervention Type: DRUG

E2/DRSP (BAY 86-4891) dose 3 (80458755)

Single dose administration of E2 + DRSP as a tablet

Intervention Type: DRUG

E2/DRSP (BAY 86-4891) dose 4 (80458720)

Single dose administration of E2 + DRSP as a tablet

Intervention Type: DRUG

E2/DRSP (BAY 86-4891) dose 5 (80458712)

Single dose administration of E2 + DRSP as a tablet

Intervention Type: DRUG

DRSP (ZK 30595) dose 1 (SH T04984F)

Single dose administration of DRSP as a tablet

Intervention Type: DRUG

DRSP (ZK 30595) dose 2 (80458690)

Single dose administration of DRSP as a tablet

Intervention Type: DRUG

Placebo

Placebo administration in each arm

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy female volunteers
• Age: 18 - 35 years (inclusive), smokers must not be older than 30 years at inclusion
• History of regular cyclic menstrual periods (with a cycle length between 25 and 35 days)
• Willingness to use barrier methods of contraception (condoms with spermicide, diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during the trial

Exclusion Criteria

• Pregnancy, lactation (less than three menstrual cycles before Visit 1 following delivery, abortion, or lactation) - Obesity (BMI > 30.0 kg/m2)
• Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at Visit 1 or a normal result has to be documented within the last 6 months before Visit 1)
• Laboratory values outside inclusion range at Screening - Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results, as e.g.: - Cardiovascular -- 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, including prodromi (e.g., transient ischemic attack, angina pectoris) and conditions which could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. -- uncontrolled arterial hypertension (repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
• Liver -- presence or history of liver tumor (benign or malignant) -- presence or history of severe hepatic disease as long as liver function values have not returned to normal -- jaundice and/or pruritus related to cholestasis -- history of cholestatic jaundice associated with pregnancy or previous COC use
• Metabolic diseases -- uncontrolled diabetes mellitus with vascular involvement severe dyslipoproteinemia
• Other diseases: any known or suspected malignant or premalignant disease, uncontrolled thyroid disorder, chronic inflammatory bowel disease, severe renal insufficiency or acute renal failure, hemolytic uremic syndrome, sickle cell anemia, porphyria, history of hypertriglyceridemia-associated Pancreatitis, systemic lupus erythematodes, pemphigoid gestationis during a previous pregnancy, Sydenham chorea, herpes gestationis, otosclerosis-related hearing loss, history of migraine with focal neurologic symptoms, epilepsy, current or history of clinically significant depression, hereditary angioedema
• Additional sex steroids, other hormonal contraceptive methods (oral, transdermal) during treatment (blister in use at randomization should be finished); intra-uterine devices (IUD) with or without hormone release within 1 month prior to Visit 1, implants within 1 month prior Visit 1, depot progestins within 6 months prior to Visit 1 - Surgical interventions scheduled in the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Krumbach, Bavaria, Germany

Nuremberg, Bavaria, Germany

Hamburg, City state of Hamburg, Germany

Hamburg, City state of Hamburg, Germany

Dietzenbach, Hesse, Germany

Frankfurt am Main, Hesse, Germany

Frankfurt am Main, Hesse, Germany

Fulda, Hesse, Germany

Mühlheim am Main, Hesse, Germany

Dippoldiswalde, Saxony, Germany

Dresden, Saxony, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Leipzig, Saxony, Germany

Wurzen, Saxony, Germany

Blankenburg, Saxony-Anhalt, Germany

Burg, Saxony-Anhalt, Germany

Jessen, Saxony-Anhalt, Germany

Magdeburg, Saxony-Anhalt, Germany

Magdeburg, Saxony-Anhalt, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Gera, Thuringia, Germany

Countries

Germany

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2007-005258-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

311926

Identifier Type: OTHER

Identifier Source: secondary_id

91765

Identifier Type: -

Identifier Source: org_study_id