DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oral Contraceptive; Headache; Pelvic Pain

Intervention: EV/DNG (Qlaira, BAY86-5027) (Drug); Encapsulated Microgynon + Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

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

Secondary outcome:

Rescue medication consumption

Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28

Prevalence of individual hormone-related symptoms during cycle days 1 to 21

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

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

Bleeding pattern and cycle control

QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)

AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight

General physical and gynecological examination

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Women with any contraindication for oral contraceptive use

Locations and Contacts

Dextra Munkkivuoren Lääkärikeskus Oy, Helsinki 00350, Finland

Lääkärikeskus Mehiläinen Töölö, Helsinki 00260, Finland

Väestöliitto, Seksuaaliterveysklinikka, Helsinki, Helsinki 00100, Finland

Laboratorio Simpanen, Kuopio 70100, Finland

Lääkäriasema Cantti Oy, Kuopio 70110, Finland

Dr. Jocelyne Nataf-Maurin, Brignoles 83170, France

Dr Matuchansky, Maison Lafitte 78600, France

Maternité Adolphe PINARD, Nancy 54042, France

Cabinet Médical Dr Honthaas, Cohen-Sourdille et De Reilhac, Nantes 44000, France

Hôpital Mère et Enfants - CHU NANTES, Nantes 44093, France

Cabinet Médical - Loiret - Olivet, Olivet 45160, France

Cabinet Médical - Villersexel - Paris, Paris 75007, France

Cabinet médical Dr Patricia Rérolle, Paris 75015, France

Dr Cecile Petrequin, Paris 75018, France

Cabinet gynecologie, Saint Germain En Laye 78100, France

Groupe Médical Ardaens Rohart Dewailly, Seclin 59113, France

Dr. Gwendoline Servan, Tarare 69170, France

Dr. Aliette Siboni-Frisch, Toulouse 31000, France

Praxis Hr. Dr. T. Gent, Hamburg 22359, Germany

Centro Médico Del Valle, Mexico, D.F. 3100, Mexico

Hospital Juárez de México SS, México, D.F. 07760, Mexico

Clínica Diatros, Barcelona 08013, Spain

Gabinete Médico Velázquez, Madrid 28001, Spain

Inselspital Bern, Bern 3010, Switzerland

Praxis Dr. Christoph Koenig, Bern 3013, Switzerland

Universitätsspital Zürich, Zürich 8091, Switzerland

Chulalongkorn Hospital, Bangkok 10330, Thailand

Ramathibodhi Hospital, Bangkok 10400, Thailand

Siriraj Hospital, Mahidol, Bangkok 10700, Thailand

Queen Charlottes & Chelseas Hospital, London W12 0NN, United Kingdom

Centro de Salud Rincón de Loix, Benidorm, Alicante 03503, Spain

Centro de Salud Petrer, Petrer, Alicante 03610, Spain

Centro de Salud Natahoyo-Tremañes, Gijón, Asturias 33212, Spain

Praxis Hr. Dr. S. Schönian, Rheinstetten, Baden-Württemberg 76287, Germany

Universitätsspital Basel, Basel, Basel-Stadt 4031, Switzerland

Hospital del Mar, Barcelona, Catalunya 08003, Spain

Bridge House Medical Centre, Cheadle, Cheshire SK8 5LL, United Kingdom

Praxis Hr. Dr. Werner Göttker-Schnetmann, Frankfurt, Hessen 60322, Germany

MeDiNova Research, Northwood, Middlesex HA6 2RN, United Kingdom

Instituto Mexicano de Investigacion Clinica, SA de CV., Mexico, México 06700, Mexico

Nuevo Sanatorio Durango S.A. de C.V., Mexico, México 06700, Mexico

Sydney Centre for Reproductive Health Reseach, Ashfield, New South Wales 2031, Australia

ACRO c/- Pacific Medical Centre, Blacktown, New South Wales 2148, Australia

Caringbah Medical and Dental Centre, Caringbah, New South Wales 2229, Australia

Royal Hospital for Women, Sydney, New South Wales 2031, Australia

Praxis Hr. Dr. K. Greven, Hannover, Niedersachsen 30459, Germany

ClinPharm International GmbH&CoKG, Bochum, Nordrhein-Westfalen 44787, Germany

Praxis Hr. Dr. H. Gerlach, Essen, Nordrhein-Westfalen 45127, Germany

Praxis Dr. S. Mucha & Dr. G. Schalk, Wuppertal, Nordrhein-Westfalen 42103, Germany

Clarence Park Surgery, Weston-super-Mare, North Somerset BS23 4BP, United Kingdom

Greenwood and Sneinton Family Medical Centre, Nottingham, Nottinghamshire NG2 4PJ, United Kingdom

Family Planning Queensland, Fortitude Valley, Queensland 4006, Australia

Peninsula Specialist Centre, Kipparing, Queensland 4021, Australia

ClinPharm International GmbH, Dresden, Sachsen 01067, Germany

ClinPharm International GmbH and Co. KG, Leipzig, Sachsen 04103, Germany

Praxis Hr. Prof. Dr. H.-J. Ahrendt, Magdeburg, Sachsen-Anhalt 39126, Germany

Universitätsklinikum Schleswig-Holstein / AÖR, Lübeck, Schleswig-Holstein 23538, Germany

Hospital Integral de la Mujer del Estado de Sonora, Hermosillo, Sonora 83100, Mexico

University of Adelaide, Adelaide, South Australia 5005, Australia

Burnside Clinical Trials Unit, Norwood, South Australia 5065, Australia

Castlemilk Health Centre, Glasgow, Stratchclyde G45 9AW, United Kingdom

Jean Hailes Foundation for Womens Health, Clayton, Victoria 3163, Australia

Queen Elizabeth II Medical Centre, Nedlands, Western Australia 6009, Australia

King Edward Memorial Hospital, Subiaco, Western Australia 6008, Australia

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Starting date: December 2008
Last updated: December 30, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017