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NCT Number: NCT01892904

Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea

The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period).

The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation period.

In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients treated for one year will be investigated.

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Matsudo, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- Dysmenorrhea patients with a total dysmenorrhea score (sum of the two sub-scores: severity of dysmenorrhea and use of analgesics) of at least 3 points in each of the last two menstruations before randomization (baseline observation phase)

  • Patients with dysmenorrheic pain during the 2 baseline cycles before randomization. Dysmenorrheic pain means any spasmodic pelvic pain or lower abdominal pain with possible radiation towards back or thighs recorded in the Patient Diary in correspondence with a withdrawal and/or menstrual bleeding episode. Pain could start up to 2 days before the onset of the bleeding episode the bleeding and terminates on the last day of bleeding of before
  • Patients having the regular cyclic menstrual period (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
  • Willingness to use a barrier method (i.e., non-hormonal method) for contraception during the study. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device.

Exclusion criteria

- Patients who have organic diseases of which surgical treatment is prioritized by the investigator

  • Patients aged 40 years or older with ovarian chocolate cysts being more than 10 cm in size of the longest diameters
  • Patients with ovarian chocolate cysts having solid part in the cyst
  • Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)

Treatment and study plan

EE20/DRSP(BAY86-5300)

Drug

One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day

Primary outcomes

  1. Number of days with dysmenorrheic pain over 140 days of evaluation period

    Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days

    Number of days with dysmenorrheic pain is determined based on daily record of Patient Diary.

Secondary outcomes

  1. Change in Dysmenorrhea score from baseline to period of withdrawal bleeding

    Time frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days

    Dysmenorrhea score is a sum of the two sub-scores, severity of dysmenorrhea and use of analgesics, recorded by the participant at every visit

  2. Change of severity of pain Description

    Time frame: Baseline period (8 weeks before start of treatment) and evaluation period which starts on 25th day after start of treatment and lasts for 140 days

    The severity of pain is measured by the Visual Analogue Scale (VAS), recorded by the participant at any visit.

  3. Number of days with at least moderate dysmenorrheic pain over 140 days of evaluation period

    Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days

    Number of days with at least moderate dysmenorrheic pain is determined based on daily record of Patient Diary.

  4. Number of days with rescue medicine used for relief of dysmenorrhea or pelvic pain over 140 days of evaluation period

    Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days

    Number of days with rescue medicine is determined based on daily record of Patient Diary.

  5. Number of days with interference of dysmenorrheic pain with daily activity over 140 days of evaluation period

    Time frame: Evaluation period which starts on 25th day after start of treatment and lasts for 140 days

    Number of days with interference of dysmenorrheic pain with daily activity is determined based on daily record of Patient Diary

  6. Endometrial thickness

    Time frame: 24 weeks after taking the initial study medication

    Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.

  7. Number of days with bleeding and spotting over treatment phase

    Time frame: Up to 24 weeks

    Number of days with spotting/bleeding is determined based on daily record of Patient Diary.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2013
Registry last updated
Sep 9, 2015

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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