Comparative tolerability of estradiol valerate/dienogest to Microgynon

• Research type

  Research Study

• Full title

  A multicenter, randomised, double-blind, active-controlled, parallel group, 2-arm study to investigate the effect of estradiol valerate/dienogest compared To Microgynon on hormone withdrawal associated symptoms in otherwise Healthy women after 6 cycles of treatment

• IRAS ID

  4437

• Contact name

  Ali Kubba

• Sponsor organisation

  Bayer HealthCare AG- Judy Kelly

• Eudract number

  2008-003226-42

• ISRCTN Number

  ISRCTN

• Clinicaltrials.gov Identifier

  NTC

• Research summary

  Oral contraceptives are the most common method of reversible birth control. Despite the continuous reduction in hormone content since oral contraceptive introduction almost 50 years ago, side effects continue to affect compliance. These symptoms often occur in the hormone-free interval. Shortening the hormone-free interval from 7 to 4 or 2 days could decrease the number of days with symptoms. Adding oestrogen during the typical 7 hormone-free days also could provide better ovarian suppression and reduce symptoms.The aim of this study is to reduce hormone-withdrawal associated symptoms, namely headache and pelvic pain whilst taking oral contraceptives. The study will compare the effects of a novel compound, Qlaira/Drug A, to Microgynon/Drug B, a well-established oral contraceptive. Drug A should demonstrate superiority to Drug B with primary regard to* hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28Secondary, comparisons of Drug A to Drug B should demonstrate an improvement of: * bloating or swelling, breast tenderness, nausea or vomiting during the hormone free interval, * change in frequency and intensity of hormone related symptoms* pain killer consumptionThe duration of the study will be approximately 26 months involving 656 patients, with 449 receiving treatment (approximately 75 study centres in 9 countries). Study drug administration will extend over a total of 168 days (i.e. 6 cycles of 28 days each).Administration of Drug A or Drug B will be randomly assigned. Tablets are encapsulated for blinding purposes. There will be no pill-free interval between the consecutive cycles of the study medication. Study treatment for all patients will cease upon completion of the trial. A reduction in those symptoms, named previously, could further improve acceptance and long-term use, with increased tolerance and non contraceptive benefits of oral contraceptives

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/77

• Date of REC Opinion

  2 Mar 2009

• REC opinion

  Further Information Favourable Opinion