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Completed

NCT Number: NCT00778609

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

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).

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Key information

Conditions

Oral Contraceptive Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ashfield, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027)

Drug

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

Encapsulated Microgynon + Placebo

Drug

Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo

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

    Time frame: Baseline to cycle 6

Secondary outcomes

  1. Rescue medication consumption

    Time frame: Baseline to cycle 6

  2. 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

  3. Prevalence of individual hormone-related symptoms during cycle days 1 to 21

    Time frame: Baseline to cycle 6

  4. 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

  5. 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

  6. Bleeding pattern and cycle control

    Time frame: Throughout

  7. 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

  8. AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight

    Time frame: Throughout

  9. General physical and gynecological examination

    Time frame: Screening and Final Visit

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2008
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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