Clinical trial NCT00778609: Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Contraceptive
Headache
Pelvic Pain
Keywords: Combined Oral Contraceptives
Pelvic Pain
Headache
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 449
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline to cycle 6
Secondary outcomes:
measure: Rescue medication consumption
timeFrame: Baseline to cycle 6
measure: Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
timeFrame: Baseline to cycle 6
measure: Prevalence of individual hormone-related symptoms during cycle days 1 to 21
timeFrame: Baseline to cycle 6
measure: 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
timeFrame: Baseline, cycle 3 and cycle 6
measure: 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
timeFrame: Baseline to cycle 3
measure: Bleeding pattern and cycle control
timeFrame: Throughout
measure: 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
measure: AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
timeFrame: Throughout
measure: General physical and gynecological examination
timeFrame: Screening and Final Visit
Other outcomes:
Locations:
city: Ashfield
country: Australia
state: New South Wales
city: Blacktown
country: Australia
state: New South Wales
city: Caringbah
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Fortitude Valley
country: Australia
state: Queensland
city: Kipparing
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Norwood
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Subiaco
country: Australia
state: Western Australia
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Kuopio
country: Finland
city: Brignoles
country: France
city: Maison Lafitte
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Nantes
country: France
city: Olivet
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Saint Germain En Laye
country: France
city: Seclin
country: France
city: Tarare
country: France
city: Toulouse
country: France
city: Rheinstetten
country: Germany
state: Baden-Württemberg
city: Frankfurt
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Bochum
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Hamburg
country: Germany
city: Mexico
country: Mexico
state: México
city: Hermosillo
country: Mexico
state: Sonora
city: Mexico, D.F.
country: Mexico
city: México, D.F.
country: Mexico
city: Benidorm
country: Spain
state: Alicante
city: Petrer
country: Spain
state: Alicante
city: Gijón
country: Spain
state: Asturias
city: Barcelona
country: Spain
state: Catalunya
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Basel
country: Switzerland
state: Basel-Stadt
city: Bern
country: Switzerland
city: Bern
country: Switzerland
city: Zürich
country: Switzerland
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Cheadle
country: United Kingdom
state: Cheshire
city: Northwood
country: United Kingdom
state: Middlesex
city: Weston-super-Mare
country: United Kingdom
state: North Somerset
city: Nottingham
country: United Kingdom
state: Nottinghamshire
city: Glasgow
country: United Kingdom
state: Stratchclyde
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Macias G, Merki-Feld GS, Parke S, Mellinger U, Serrani M. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol. 2013 Aug;33(6):591-6. doi: 10.3109/01443615.2013.800851.