check_circleStudy Completed

Oral Contraceptive

Bayer Identifier:

14567

ClinicalTrials.gov Identifier:

NCT01076582

EudraCT Number:

2009-014911-11

EU CT Number:

Not Available
Comparative trial in hormone withdrawal associated symptoms

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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).

Trial summary

Enrollment Goal
592
Trial Dates
April 2010 - October 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Praxis Fr. Dr. B. FechtelJena, 07747, Germany
Completed
Queen Charlottes & Chelseas HospitalLondon, W12 0HS, United Kingdom
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
Nestatni zdravotnicke zarizeni MUDr. Vladimir DvorakBrno, 602 00, Czech Republic
Completed
Dr. Smrhova-KovacsTabor, 39003, Czech Republic
Completed
Centro Hospitalar de Lisboa Norte - Hospital Santa MariaLisboa, 1649-035, Portugal
Completed
Sanatorio MAPACIRosario, 2000, Argentina
Terminated
Hospital Clínico Universidad de ChileSantiago, 838-0456, Chile
Completed
Corporación SERJOVENSantiago, Chile
Completed
Centro de Investigación Clinica Universidad del RosarioBogotá, Colombia
Terminated
Endocrinology Scientific CentreMoscow, 117036, Russia
Terminated
Scientific Research Center of Obst., Gyn. and PerinatologyMoscow, 177997, Russia
Terminated
City Clinical Hospital no 72Moscow, 123995, Russia
Completed
Universitätsklinikum HeidelbergHeidelberg, 69115, Germany
Terminated
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Terminated
EuromedClinicFürth, 90763, Germany
Terminated
Leeds Student Medical PracticeLeeds, LS2 9AE, United Kingdom
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
Gynprofi s.r.o.Praha 2, 120 00, Czech Republic
Completed
Maternidade Bissaya BarrretoCoimbra, 3000-061, Portugal
Completed
Hospital de São JoãoPorto, 4200-319, Portugal
Terminated
Hospital Bernardino RivadaviaBuenos Aires, C1425ASQ, Argentina
Completed
Consultorio MirafloresTemuco, 4790711, Chile
Completed
Consultorio Dr. VeraSantiago, 7510025, Chile
Completed
Fundación Centro de Investigación ClinicaMedellín, Colombia
Terminated
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Terminated
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Cheil general HospitalSeoul, 100-380, Korea, Republic Of
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Inselspital BernBern, 3010, Switzerland
Completed
The Medical CityPasig City, Philippines
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
King Chulalongkorn Memorial HospitalBangkok, 10330, Thailand
Completed
Prince of Songkla UniversitySongkla, 90110, Thailand
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Kantonsspital St. GallenSt. Gallen, 9007, Switzerland
Terminated
Clínica Santa SofíaCaracas, Venezuela
Terminated
Policlínica MetropolitanaCaracas, Venezuela
Terminated
Centro Médico Docente La TrinidadCaracas, Venezuela
Completed
UP Manila PGHManila, Philippines
Completed
May Logan CentreLiverpool, L20 5DQ, United Kingdom
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Dr. Juan Carolos MonteroSantiago de Chile, Chile
Completed
Instituto Chileno de Medicina ReproductivaSantiago de Chile, Chile
Completed
Hospital Clínico San Borja ArriaránSantiago de Chile, 836-0156, Chile
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
ICAMEDICBucaramanga, Colombia
Terminated
Clínica MedellínMedellín, Colombia
Terminated
Clínica del CountryBogotá, Colombia

Primary Outcome

  • 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).
    date_rangeTime Frame:
    Cycle days 22 - 28 of baseline cycle and cycle 4.
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • 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),
    date_rangeTime Frame:
    Cycle days 22 - 28 of baseline cycle and cycle 4
    enhanced_encryption
    Safety Issue:
    no
  • 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),
    date_rangeTime Frame:
    Cycle days 22 - 28 of baseline cycle and cycle 4
    enhanced_encryption
    Safety Issue:
    no
  • change from baseline to cycle 4 in maximum intensity of individual hormone withdrawal symptoms on cycle days 22 - 28,
    date_rangeTime Frame:
    Cycle days 22 - 28 of baseline cycle and cycle 4
    enhanced_encryption
    Safety Issue:
    no
  • rescue medication consumption
    date_rangeTime Frame:
    baseline cycle and cycle 4
    enhanced_encryption
    Safety Issue:
    no
  • bleeding pattern
    date_rangeTime Frame:
    reference period is 90 days.
    enhanced_encryption
    Safety Issue:
    no
  • evaluation of questionnaires: Q-LES-Q (short version)
    date_rangeTime Frame:
    baseline cycle and cycle 4
    enhanced_encryption
    Safety Issue:
    no
  • Adverse Event collection
    date_rangeTime Frame:
    up to 10 days after end of cycle 4
    enhanced_encryption
    Safety Issue:
    yes
  • heart rate
    date_rangeTime Frame:
    up to 10 days after end of cycle 4
    enhanced_encryption
    Safety Issue:
    yes
  • blood pressure
    date_rangeTime Frame:
    up to 10 days after end of cycle 4
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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