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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2016
• Main ID: NCT00778609
• Date of registration: 22/10/2008
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
• Scientific 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
• Date of first enrolment: December 2008
• Target sample size: 449
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00778609
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Australia, Finland, France, Germany, Mexico, Spain, Switzerland, Thailand, United Kingdom

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Headache

Oral Contraceptive

Pelvic Pain

Intervention(s)

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

Drug: Encapsulated Microgynon + Placebo

Primary Outcome(s)

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 [Time Frame: Baseline to cycle 6]

Secondary Outcome(s)

General physical and gynecological examination [Time Frame: Screening and Final Visit]

QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI) [Time Frame: Baseline, cycle 2 and cycle 5]

Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28 [Time Frame: Baseline to cycle 6]

AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight [Time Frame: Throughout]

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 [Time Frame: Baseline to cycle 3]

Prevalence of individual hormone-related symptoms during cycle days 1 to 21 [Time Frame: 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 [Time Frame: Baseline, cycle 3 and cycle 6]

Bleeding pattern and cycle control [Time Frame: Throughout]

Rescue medication consumption [Time Frame: Baseline to cycle 6]

Secondary ID(s)

91550

2008-003226-42

310787

Source(s) of Monetary Support

Please refer to primary and secondary sponsors