Status:
COMPLETED
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
Lead Sponsor:
Bayer
Conditions:
Oral Contraceptive
Headache
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
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 sy...
Eligibility Criteria
Inclusion
- 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
- Women with any contraindication for oral contraceptive use
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT00778609
Start Date
December 1 2008
End Date
December 1 2010
Last Update
January 14 2016
Active Locations (63)
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1
Ashfield, New South Wales, Australia, 2031
2
Blacktown, New South Wales, Australia, 2148
3
Caringbah, New South Wales, Australia, 2229
4
Sydney, New South Wales, Australia, 2031