Trial Condition(s):
Oral Contraceptive, Headache, Pelvic Pain
Effect of a new oral contraceptive pill on hormone related symptoms such as pelvic pain and headache
Bayer Identifier:
91550
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Praxis Hr. Prof. Dr. H.-J. Ahrendt Magdeburg, Germany, 39126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Gerlach Essen, Germany, 45127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Greven Hannover, Germany, 30459 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Mucha & Dr. G. Schalk Wuppertal, Germany, 42103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ClinPharm International GmbH Dresden, Germany, 01067 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Charlottes & Chelseas Hospital London, United Kingdom, W12 0NN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Greenwood and Sneinton Family Medical Centre Nottingham, United Kingdom, NG2 4PJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maternité Adolphe PINARD Nancy, France, 54042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Mère et Enfants - CHU NANTES Nantes, France, 44093 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Matuchansky Maison Lafitte, France, 78600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Jocelyne Nataf-Maurin Brignoles, France, 83170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Villersexel - Paris PARIS, France, 75007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical Dr Honthaas, Cohen-Sourdille et De Reilhac NANTES, France, 44000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Groupe Médical Ardaens Rohart Dewailly SECLIN, France, 59113 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gabinete Médico Velázquez Madrid, Spain, 28001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Integral de la Mujer del Estado de Sonora Hermosillo, Mexico, 83100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico Del Valle Mexico, D.F., Mexico, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Juárez de México SS México, D.F., Mexico, 07760 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nuevo Sanatorio Durango S.A. de C.V. Mexico, Mexico, 06700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth II Medical Centre Nedlands, Australia, 6009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peninsula Specialist Centre Kipparing, Australia, 4021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Caringbah Medical and Dental Centre Caringbah, Australia, 2229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Zürich Zürich, Switzerland, 8091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Laboratorio Simpanen Kuopio, Finland, 70100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chulalongkorn Hospital Bangkok , Thailand, 10330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. T. Gent Hamburg, Germany, 22359 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Schleswig-Holstein / AÖR Lübeck, Germany, 23538 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ClinPharm International GmbH&CoKG Bochum, Germany, 44787 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. S. Schönian Rheinstetten, Germany, 76287 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Werner Göttker-Schnetmann Frankfurt , Germany, 60322 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ClinPharm International GmbH and Co. KG Leipzig, Germany, 04103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Castlemilk Health Centre Glasgow, United Kingdom, G45 9AW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clarence Park Surgery Weston-super-Mare, United Kingdom, BS23 4BP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MeDiNova Research Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bridge House Medical Centre Cheadle, United Kingdom, SK8 5LL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Cecile Petrequin Paris, France, 75018 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Loiret - Olivet OLIVET, France, 45160 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet gynecologie SAINT GERMAIN EN LAYE, France, 78100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Gwendoline Servan TARARE, France, 69170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Aliette Siboni-Frisch Toulouse, France, 31000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet médical Dr Patricia Rérolle PARIS, France, 75015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Diatros Barcelona, Spain, 08013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Natahoyo-Tremañes Gijón, Spain, 33212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Rincón de Loix Benidorm, Spain, 03503 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Salud Petrer Petrer, Spain, 03610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Mexicano de Investigacion Clinica, SA de CV. Mexico, Mexico, 06700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Hospital for Women Sydney, Australia, 2031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Family Planning Queensland Fortitude Valley, Australia, 4006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations King Edward Memorial Hospital Subiaco, Australia, 6008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Adelaide Adelaide, Australia, 5005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sydney Centre for Reproductive Health Reseach Ashfield, Australia, 2031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Burnside Clinical Trials Unit Norwood, Australia, 5065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jean Hailes Foundation for Womens Health Clayton, Australia, 3163 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ACRO c/- Pacific Medical Centre Blacktown, Australia, 2148 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Christoph Koenig Bern, Switzerland, 3013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lääkäriasema Cantti Oy Kuopio, Finland, 70110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dextra Munkkivuoren Lääkärikeskus Oy Helsinki, Finland, 00350 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Väestöliitto, Seksuaaliterveysklinikka, Helsinki Helsinki, Finland, 00100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lääkärikeskus Mehiläinen Töölö Helsinki, Finland, 00260 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ramathibodhi Hospital Bangkok, Thailand, 10400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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 endpointTimeframe: Baseline to cycle 6
Secondary Outcome
- Rescue medication consumptionTimeframe: Baseline to cycle 6
- Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28Timeframe: Baseline to cycle 6
- Prevalence of individual hormone-related symptoms during cycle days 1 to 21Timeframe: Baseline to cycle 6
- 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 comparatorTimeframe: Baseline, cycle 3 and cycle 6
- 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 3Timeframe: Baseline to cycle 3
- Bleeding pattern and cycle controlTimeframe: Throughout
- QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)Timeframe: Baseline, cycle 2 and cycle 5
- AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weightTimeframe: Throughout
- General physical and gynecological examinationTimeframe: Screening and Final Visit
Additional Information
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