Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination; Hormones

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