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Cycle Control and Safety of E2-DRSP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00653614
First received: April 2, 2008
Last updated: June 4, 2014
Last verified: June 2014
  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.


Condition Intervention Phase
Oral Contraceptive
Drug: E2/DRSP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of intracyclic bleeding episodes during cycles 2 to 7 [ Time Frame: During six cycles of intake of the investigational drug 196 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of bleeding patterns and cycle control [ Time Frame: During seven cycles of intake of the investigational drug ] [ Designated as safety issue: No ]
  • Comparison of safety of the different treatment regimens [ Time Frame: During seven cycles of intake of the investigational drug ] [ Designated as safety issue: Yes ]

Enrollment: 635
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: E2/DRSP
Monophasic regimen containing estrogen and progestin
Experimental: Arm 2 Drug: E2/DRSP
Monophasic regimen containing estrogen and progestin
Experimental: Arm 3 Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin
Experimental: Arm 4 Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin
Experimental: Arm 5 Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin
Experimental: Arm 6 Drug: E2/DRSP
Triphasic regimen containing estrogen and progestin

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653614

Locations
Germany
Krumbach, Bayern, Germany, 86381
Nürnberg, Bayern, Germany, 90491
Dietzenbach, Hessen, Germany, 63128
Frankfurt, Hessen, Germany, 60322
Frankfurt, Hessen, Germany, 65936
Fulda, Hessen, Germany, 36037
Mühlheim, Hessen, Germany, 63165
Blankenburg, Sachsen-Anhalt, Germany, 38889
Burg, Sachsen-Anhalt, Germany, 39288
Jessen, Sachsen-Anhalt, Germany, 06917
Magdeburg, Sachsen-Anhalt, Germany, 39104
Magdeburg, Sachsen-Anhalt, Germany, 39126
Dippoldiswalde, Sachsen, Germany, 01744
Dresden, Sachsen, Germany, 01099
Dresden, Sachsen, Germany, 01169
Leipzig, Sachsen, Germany, 04207
Leipzig, Sachsen, Germany, 04299
Wurzen, Sachsen, Germany, 04808
Gera, Thüringen, Germany, 07545
Berlin, Germany, 12587
Berlin, Germany, 13086
Berlin, Germany, 10247
Berlin, Germany, 13507
Hamburg, Germany, 22159
Hamburg, Germany, 21073
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00653614     History of Changes
Other Study ID Numbers: 91765, 2007-005258-22, 311926
Study First Received: April 2, 2008
Last Updated: June 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Oral contraception

ClinicalTrials.gov processed this record on November 20, 2014