Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
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
3 other identifiers
interventional
449
9 countries
63
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2008
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2008
CompletedFirst Posted
Study publicly available on registry
October 23, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 14, 2016
January 1, 2016
2 years
October 22, 2008
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline to cycle 6
Secondary Outcomes (9)
Rescue medication consumption
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 28
Baseline to cycle 6
Prevalence of individual hormone-related symptoms during cycle days 1 to 21
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 comparator
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 3
Baseline to cycle 3
- +4 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval
Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women with any contraindication for oral contraceptive use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (63)
Unknown Facility
Ashfield, New South Wales, 2031, Australia
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Blacktown, New South Wales, 2148, Australia
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Caringbah, New South Wales, 2229, Australia
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Sydney, New South Wales, 2031, Australia
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Fortitude Valley, Queensland, 4006, Australia
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Kipparing, Queensland, 4021, Australia
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Adelaide, South Australia, 5005, Australia
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Norwood, South Australia, 5065, Australia
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Clayton, Victoria, 3163, Australia
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Nedlands, Western Australia, 6009, Australia
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Subiaco, Western Australia, 6008, Australia
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Helsinki, 00100, Finland
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Helsinki, 00260, Finland
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Helsinki, 00350, Finland
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Kuopio, 70100, Finland
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Kuopio, 70110, Finland
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Paris, Paris, 75018, France
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Brignoles, 83170, France
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Maison Lafitte, 78600, France
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Nancy, 54042, France
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Nantes, 44000, France
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Nantes, 44093, France
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Olivet, 45160, France
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Paris, 75007, France
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Paris, 75015, France
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Saint-Germain-en-Laye, 78100, France
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Seclin, 59113, France
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Tarare, 69170, France
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Toulouse, 31000, France
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Rheinstetten, Baden-Wurttemberg, 76287, Germany
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Hamburg, Hamburg, 22359, Germany
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Frankfurt am Main, Hesse, 60322, Germany
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Hanover, Lower Saxony, 30459, Germany
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Bochum, North Rhine-Westphalia, 44787, Germany
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Essen, North Rhine-Westphalia, 45127, Germany
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Wuppertal, North Rhine-Westphalia, 42103, Germany
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Dresden, Saxony, 01067, Germany
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Leipzig, Saxony, 04103, Germany
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Magdeburg, Saxony-Anhalt, 39126, Germany
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Lübeck, Schleswig-Holstein, 23538, Germany
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Hermosillo, Sonora, 83100, Mexico
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México, State of Mexico, 06700, Mexico
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Mexico City, 3100, Mexico
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México, D.F., 07760, Mexico
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Benidorm, Alicante, 03503, Spain
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Petrel, Alicante, 03610, Spain
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Barcelona, Barcelona, 08013, Spain
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Barcelona, Catalonia, 08003, Spain
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Madrid, Madrid, 28001, Spain
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Gijón, Principality of Asturias, 33212, Spain
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Basel, Canton of Basel-City, 4031, Switzerland
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Bern, Canton of Bern, 3010, Switzerland
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Zurich, Canton of Zurich, 8091, Switzerland
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Bern, 3013, Switzerland
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Cheadle, Cheshire, SK8 5LL, United Kingdom
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Northwood, Middlesex, HA6 2RN, United Kingdom
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Weston-super-Mare, North Somerset, BS23 4BP, United Kingdom
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Nottingham, Nottinghamshire, NG2 4PJ, United Kingdom
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Glasgow, Stratchclyde, G45 9AW, United Kingdom
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London, W12 0NN, United Kingdom
Related Publications (1)
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.
PMID: 23919857DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2008
First Posted
October 23, 2008
Study Start
December 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 14, 2016
Record last verified: 2016-01