check_circleStudy Completed

Contraceptive, oral, hormonal

Bayer Identifier:

91765

ClinicalTrials.gov Identifier:

NCT00653614

EudraCT Number:

2007-005258-22

EU CT Number:

Not Available
Cycle control and safety of E2-DRSP

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

  • - 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

  • - 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

Trial summary

Enrollment Goal
635
Trial Dates
March 2008 - June 2009
Phase
Phase 2
Could I Receive a placebo
Yes
Products
E2/DRSP (BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kreiskrankenhaus KrumbachKrumbach, 86381, Germany
Completed
Kreiskrankenhaus KrumbachKrumbach, 86381, Germany
Completed
Praxis Hr. Dr. Karl-Heinz BellingBerlin, 13086, Germany
Completed
Praxis Fr. Dr. B. HeubergerBerlin, 12587, Germany
Completed
Praxis Fr. Dr. K. MaarBerlin, 13507, Germany
Completed
Praxis Hr. Dr. Werner Göttker-SchnetmannFrankfurt, 60322, Germany
Completed
Praxis Fr. Dr. J. TyagiMühlheim, 63165, Germany
Completed
Praxis Fr. Dr. G. GollnickDresden, 01099, Germany
Completed
Frauenarztpraxis Dr. Robert HantschelDippoldiswalde, 01744, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Praxis Fr. Dr. A. BrauneMagdeburg, 39104, Germany
Completed
Frauenarztpraxis Dipl. med. Michael StellmacherBurg, 39288, Germany
Completed
Praxis Hr. H. ThelenJessen, 06917, Germany
Completed
Praxis Hr. Dr. R. EtzrodtGera, 07545, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Praxis Hr. Dr. R. KuettNürnberg, 90491, Germany
Completed
Frauenarztpraxis Hr. Dr. H. LindeckeBerlin, 10247, Germany
Completed
Praxis Hr. Dr. K. PetersHamburg, 22159, Germany
Completed
Praxis Hr. Dr. D. RautenbergHamburg, 21073, Germany
Completed
Frauenarztpraxis Dr. med. Wolfram BrachDietzenbach, 63128, Germany
Completed
Praxis Dr. LarbigFulda, 36037, Germany
Completed
Praxis Hr. Dr. P. SchwanerFrankfurt, 65936, Germany
Completed
Praxis Fr. Dr. C. BurgkhardtLeipzig, 04299, Germany
Completed
Praxis Fr. I. GrögerWurzen, 04808, Germany
Completed
Praxis Fr. Dr. K. KoppraschDresden, 01169, Germany
Completed
Praxis Hr. R. WähnertGera, 07545, Germany

Primary Outcome

  • Number of intracyclic bleeding episodes during cycles 2 to 7
    date_rangeTime Frame:
    168 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of intracyclic bleeding days (including spotting) in Cycles 2 to 7
    date_rangeTime Frame:
    168 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of withdrawal bleeding episodes in Cycles 1 to 6
    date_rangeTime Frame:
    168 days
    enhanced_encryption
    Safety Issue:
    No
  • Bleeding pattern
    Bleeding pattern was determined by: - Number of bleeding/spotting days - Number of bleeding days (excluding spotting) - Number of spotting-only days - Number, mean length, maximum length, and range of length of bleeding/spotting episodes - Number, mean length, maximum length, and range of length of spotting-only episodes
    date_rangeTime Frame:
    Approximately 7 months
    enhanced_encryption
    Safety Issue:
    No
  • Cycle control
    Withdrawal bleeding - Number of volunteers with/without withdrawal bleeding; - Length, maximum intensity, and onset of withdrawal bleeding episodes Intracyclic bleeding (including/excluding spotting) - Number of volunteers with/without intracyclic bleeding; - Number, maximum length, maximum intensity (including spotting only) of intracyclic bleeding episodes - Number of intracyclic bleeding days - Number of volunteers with at least one intracyclic bleeding (including/excluding spotting) episode in Cycles 2 – 6 and in Cycles 2 – 7
    date_rangeTime Frame:
    Approximately 7 months
    enhanced_encryption
    Safety Issue:
    No
  • Subjective assessment of treatment
    The treatment satisfaction assessment was done through a questionaire. The investigator handed it over to the subject and the subject was asked to answer all questions by herself.
    date_rangeTime Frame:
    Day 196 - Day 210
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 7 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A multi-center, double-blind, randomized, parallel-group study to evaluate cycle control and safety of 6 different regimens of an oral contraceptive containing estradiol and drospirenone in healthy female volunteers aged between 18 and 35 years over 7 cycles
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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