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

Bayer

Status and phase: Completed; Phase 3

Conditions: Pelvic Pain; Oral Contraceptive; Headache

Treatments: Drug: Encapsulated Microgynon + Placebo; Drug: EV/DNG (Qlaira, BAY86-5027)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00778609

2008-003226-42 (EudraCT Number)

91550

310787 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 449 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

449 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: EV/DNG (Qlaira, BAY86-5027)

Arm 2

Active Comparator group

Treatment:

Drug: Encapsulated Microgynon + Placebo