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Comparative Trial in Hormone Withdrawal Associated Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01076582
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.

Condition or disease Intervention/treatment Phase
Oral Contraceptive Drug: EE20/DRSP (YAZ, BAY86-5300) Drug: Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 592 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomized, Double-blind, Active Control, Parallel-group, 2-arm Study to Investigate the Effect of Ethinylestradiol / Drospirenone (0.02 mg/3 mg) Oral Contraception in a 24/4 Regimen Compared to Ethinylestradiol / Desogestrel (0.02 mg/0.15 mg) Oral Contraception in a 21/7 Regimen on Hormone Withdrawal Associated Symptoms in Otherwise Healthy Women After 4 Cycles of Treatment
Study Start Date : April 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: EE20/DRSP (YAZ, BAY86-5300)
4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days
Active Comparator: Arm 2 Drug: Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)
4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales). [ Time Frame: Cycle days 22 - 28 of baseline cycle and cycle 4. ]

Secondary Outcome Measures :
  1. change from baseline to cycle 4 in the sum of individual scores during cycle days 22 - 28 (AUC of days 22 - 28 for each score), [ Time Frame: Cycle days 22 - 28 of baseline cycle and cycle 4 ]
  2. change from baseline to cycle 4 in number of days, where individual hormone withdrawal symptoms are present on cycle days 22 - 28 (i.e. Likert Scale >= 1), [ Time Frame: Cycle days 22 - 28 of baseline cycle and cycle 4 ]
  3. change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28, [ Time Frame: Cycle days 22 - 28 of baseline cycle and cycle 4 ]
  4. rescue medication consumption [ Time Frame: baseline cycle and cycle 4 ]
  5. bleeding pattern [ Time Frame: reference period is 90 days. ]
  6. evaluation of questionnaires: Q-LES-Q (short version) [ Time Frame: baseline cycle and cycle 4 ]
  7. Adverse Event collection [ Time Frame: up to 10 days after end of cycle 4 ]
  8. heart rate [ Time Frame: up to 10 days after end of cycle 4 ]
  9. blood pressure [ Time Frame: up to 10 days after end of cycle 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged between 18 and 35 years (inclusive)
  • Smokers with a maximum age of 30 years at time of informed consent
  • Healthy female subjects requesting contraception and currently using a low-dose EE containing oral contraceptives (OC) in a 21-day regimen (for at least three months) and suffering from at least two of the hormone withdrawal associated symptoms headache, pelvic pain and bloating during all three months prior the planned baseline cycle and requiring further OC use
  • To be valid for randomization, the total 7-day composite score of hormone-withdrawal symptoms during the baseline cycle must show an increase of at least 50% during Day 22 - 28 versus the 21-day composite score during Day 1 - 21 (21-day score divided by three [for normalization])
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • 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, or presence or history of prodrome of a thrombosis (e.g. transient ischemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APCresistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
  • History of migraine with focal neurological symptoms.
  • Diabetes mellitus with vascular involvement.
  • Obesity (Body Mass Index >32.0 kg/m2)
  • Moderate to severe hypertension (repeated measurements of systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg).
  • Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
  • 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 (Gilbert´s syndrome excepted), or history of cholestatic jaundice associated with pregnancy or previous combined OC use
  • Severe renal insufficiency or acute renal failure.
  • Presence or history of liver tumors (benign or malignant), or known or suspected sex-steroid influenced malignancies or premalignant disease (e.g. of the genital organs or the breasts).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076582


Locations
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Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425ASQ
Rosario, Santa Fe, Argentina, 2000
Chile
Santiago de Chile, Santiago, Chile, 836-0156
Santiago de Chile, Chile
Santiago, Chile, 7510025
Santiago, Chile, 838-0456
Santiago, Chile
Temuco, Chile, 4790711
Colombia
Bucaramanga, Santander, Colombia
Bogotá, Colombia
Medellín, Colombia
Czech Republic
Brno, Czech Republic, 602 00
Praha 2, Czech Republic, 120 00
Tabor, Czech Republic, 39003
Germany
Heidelberg, Baden-Württemberg, Germany, 69115
Fürth, Bayern, Germany, 90763
Hannover, Niedersachsen, Germany, 30459
Magdeburg, Sachsen-Anhalt, Germany, 39126
Leipzig, Sachsen, Germany, 04207
Jena, Thüringen, Germany, 07747
Italy
Firenze, Italy, 50134
Milano, Italy, 20132
Siena, Italy, 53100
Korea, Republic of
Seoul, Korea, Korea, Republic of, 100-380
Seoul, Korea, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 135-710
Philippines
Manila, Philippines
Pasig City, Philippines
Portugal
Coimbra, Portugal, 3000-061
Lisboa, Portugal, 1649-035
Porto, Portugal, 4200-319
Russian Federation
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 123995
Moscow, Russian Federation, 177997
Switzerland
Basel, Basel-Stadt, Switzerland, 4031
St. Gallen, Sankt Gallen, Switzerland, 9007
Bern, Switzerland, 3010
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10700
Songkla, Thailand, 90110
United Kingdom
Leeds, West Yorkshire, United Kingdom, LS2 9AE
Liverpool, United Kingdom, L20 5DQ
London, United Kingdom, W12 0HS
Venezuela
Caracas, Venezuela
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01076582    
Other Study ID Numbers: 14567
2009-014911-11 ( EudraCT Number )
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Bayer:
hormone withdrawal associated symptoms
Additional relevant MeSH terms:
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Ethinyl Estradiol
Desogestrel
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Progestins