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NCT Number: NCT01697111

Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

This is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group study (24-week treatment-comparison phase) with an open-label reference arm of active comparator (dienogest) followed by 28-week long-term treatment phase.

The primary objective of this study is to confirm the superiority of BAY86-5300 when administered with an extended flexible regimen for the treatment of endometriosis-associated pelvic pain in comparison to placebo in Japanese endometriosis patients within 24 weeks.

The secondary objective is to investigate the long-term safety of BAY86-5300 in patients treated with an extended flexible regimen for one year, and the bleeding pattern of BAY86-5300 when administered with an extended flexible regimen compared to dienogest.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Anjo, Aichi-ken, 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

  • Patients diagnosed as having endometriosis by laparotomy or laparoscopy, or by identification of chocolate cyst of endometriosis, or patients with the clinical diagnosis of endometriosis, who fulfill the condition of pelvic tenderness or induration of Cul-de-sac or uterine immobility
  • Patient with pelvic pain judged by the highest Visual Analogue Scale (VAS) value of 40 mm or higher which is determined during 2 menstrual cycles before randomization (baseline observation phase)
  • Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before randomization (baseline observation phase)
  • Patients who do not wish to become pregnant during the course of the study

Exclusion criteria

  • Patients who have organic diseases of which surgical treatment is prioritized by investigator
  • Patients in whom any hormonal therapies, including combined oral contraceptives (COCs) and progestins, have failed for treatment of symptomatic endometriosis (moderate, severe pain)
  • Patients for whom YAZ Combination Tablet is contraindicated (according to Japanese Labeling)
  • Patients for whom dienogest is contraindicated (according to Japanese labeling of Dinagest Tab 1mg)

Treatment and study plan

EE20/DRSP(BAY86-5300)

Drug

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

Placebo

Drug

One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively

Dienogest

Drug

Dienogest 1mg twice a day (bid)

Primary outcomes

  1. Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)

    Time frame: Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)

    The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)

Secondary outcomes

  1. Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)

    Time frame: Weeks 17-24 of treatment period

    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

  2. Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)

    Time frame: Weeks 17-24 of treatment period

    Pelvic pain is the worst pain on a 0-10 scale rated by the participant.

  3. Dyspareunia

    Time frame: Weeks 17-24 of treatment period

    In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.

  4. Average of pain

    Time frame: Weeks 17-24 of treatment period

    The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary.

  5. Size of chocolate cyst

    Time frame: 24 weeks after taking the initial study medication

    In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography.

  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 spotting/bleeding

    Time frame: Up to 52 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, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 2, 2012
Registry last updated
Feb 18, 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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