check_circleStudy Completed

Oral Contraceptive, Headache, Pelvic Pain

Bayer Identifier:

91550

ClinicalTrials.gov Identifier:

NCT00778609

EudraCT Number:

2008-003226-42

EU CT Number:

Not Available
Effect of a new oral contraceptive pill on hormone related symptoms such as pelvic pain and headache

Trial purpose

The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive)
    - Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of >/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28.
    - Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening)
    - Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.
  • - Women with any contraindication for oral contraceptive use

Trial summary

Enrollment Goal
449
Trial Dates
December 2008 - December 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Hr. Prof. Dr. H.-J. AhrendtMagdeburg, 39126, Germany
Completed
Praxis Hr. Dr. H. GerlachEssen, 45127, Germany
Completed
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Completed
Praxis Dr. S. Mucha & Dr. G. SchalkWuppertal, 42103, Germany
Completed
ClinPharm International GmbHDresden, 01067, Germany
Completed
Queen Charlottes & Chelseas HospitalLondon, W12 0NN, United Kingdom
Completed
Greenwood and Sneinton Family Medical CentreNottingham, NG2 4PJ, United Kingdom
Completed
Maternité Adolphe PINARDNancy, 54042, France
Completed
Hôpital Mère et Enfants - CHU NANTESNantes, 44093, France
Completed
Dr MatuchanskyMaison Lafitte, 78600, France
Completed
Dr. Jocelyne Nataf-MaurinBrignoles, 83170, France
Completed
Cabinet Médical - Villersexel - ParisPARIS, 75007, France
Completed
Cabinet Médical Dr Honthaas, Cohen-Sourdille et De ReilhacNANTES, 44000, France
Completed
Groupe Médical Ardaens Rohart DewaillySECLIN, 59113, France
Completed
Gabinete Médico VelázquezMadrid, 28001, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Hospital Integral de la Mujer del Estado de SonoraHermosillo, 83100, Mexico
Completed
Centro Médico Del ValleMexico, D.F., 3100, Mexico
Completed
Hospital Juárez de México SSMéxico, D.F., 07760, Mexico
Completed
Nuevo Sanatorio Durango S.A. de C.V.Mexico, 06700, Mexico
Completed
Queen Elizabeth II Medical CentreNedlands, 6009, Australia
Completed
Peninsula Specialist CentreKipparing, 4021, Australia
Completed
Caringbah Medical and Dental CentreCaringbah, 2229, Australia
Completed
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Inselspital BernBern, 3010, Switzerland
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Laboratorio SimpanenKuopio, 70100, Finland
Completed
Chulalongkorn HospitalBangkok, 10330, Thailand
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
Praxis Hr. Dr. T. GentHamburg, 22359, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
ClinPharm International GmbH&CoKGBochum, 44787, Germany
Completed
Praxis Hr. Dr. S. SchönianRheinstetten, 76287, Germany
Completed
Praxis Hr. Dr. Werner Göttker-SchnetmannFrankfurt, 60322, Germany
Completed
ClinPharm International GmbH and Co. KGLeipzig, 04103, Germany
Completed
Castlemilk Health CentreGlasgow, G45 9AW, United Kingdom
Completed
Clarence Park SurgeryWeston-super-Mare, BS23 4BP, United Kingdom
Completed
MeDiNova ResearchNorthwood, HA6 2RN, United Kingdom
Completed
Bridge House Medical CentreCheadle, SK8 5LL, United Kingdom
Completed
Dr Cecile PetrequinParis, 75018, France
Completed
Cabinet Médical - Loiret - OlivetOLIVET, 45160, France
Completed
Cabinet gynecologieSAINT GERMAIN EN LAYE, 78100, France
Completed
Dr. Gwendoline ServanTARARE, 69170, France
Completed
Dr. Aliette Siboni-FrischToulouse, 31000, France
Completed
Cabinet médical Dr Patricia RérollePARIS, 75015, France
Completed
Clínica DiatrosBarcelona, 08013, Spain
Completed
Centro de Salud Natahoyo-TremañesGijón, 33212, Spain
Completed
Centro de Salud Rincón de LoixBenidorm, 03503, Spain
Completed
Centro de Salud PetrerPetrer, 03610, Spain
Completed
Instituto Mexicano de Investigacion Clinica, SA de CV.Mexico, 06700, Mexico
Completed
Royal Hospital for WomenSydney, 2031, Australia
Completed
Family Planning QueenslandFortitude Valley, 4006, Australia
Completed
King Edward Memorial HospitalSubiaco, 6008, Australia
Completed
University of AdelaideAdelaide, 5005, Australia
Completed
Sydney Centre for Reproductive Health ReseachAshfield, 2031, Australia
Completed
Burnside Clinical Trials UnitNorwood, 5065, Australia
Completed
Jean Hailes Foundation for Womens HealthClayton, 3163, Australia
Completed
ACRO c/- Pacific Medical CentreBlacktown, 2148, Australia
Completed
Praxis Dr. Christoph KoenigBern, 3013, Switzerland
Completed
Lääkäriasema Cantti OyKuopio, 70110, Finland
Completed
Dextra Munkkivuoren Lääkärikeskus OyHelsinki, 00350, Finland
Completed
Väestöliitto, Seksuaaliterveysklinikka, HelsinkiHelsinki, 00100, Finland
Completed
Lääkärikeskus Mehiläinen TöölöHelsinki, 00260, Finland
Completed
Ramathibodhi HospitalBangkok, 10400, Thailand

Primary Outcome

  • To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint
    date_rangeTime Frame:
    Baseline to cycle 6
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Rescue medication consumption
    date_rangeTime Frame:
    Baseline to cycle 6
    enhanced_encryption
    Safety Issue:
    no
  • Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
    date_rangeTime Frame:
    Baseline to cycle 6
    enhanced_encryption
    Safety Issue:
    no
  • Prevalence of individual hormone-related symptoms during cycle days 1 to 21
    date_rangeTime Frame:
    Baseline to cycle 6
    enhanced_encryption
    Safety Issue:
    no
  • Prevalence of individual hormone-related symptoms during hormone-free interval, i.e. cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator
    date_rangeTime Frame:
    Baseline, cycle 3 and cycle 6
    enhanced_encryption
    Safety Issue:
    no
  • Change in the average of the 3 highest VAS values of the hormone withdrawal associated symptoms pelvic pain or headache during cycle days 22 to 28 from baseline to cycle 3
    date_rangeTime Frame:
    Baseline to cycle 3
    enhanced_encryption
    Safety Issue:
    no
  • Bleeding pattern and cycle control
    date_rangeTime Frame:
    Throughout
    enhanced_encryption
    Safety Issue:
    no
  • QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)
    date_rangeTime Frame:
    Baseline, cycle 2 and cycle 5
    enhanced_encryption
    Safety Issue:
    no
  • AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
    date_rangeTime Frame:
    Throughout
    enhanced_encryption
    Safety Issue:
    yes
  • General physical and gynecological examination
    date_rangeTime Frame:
    Screening and Final Visit
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to show superiority of the oral contraceptive SH T00658ID over Microgynon on hormone withdrawal-associated symptoms after 6 cycles of treatment
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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