A multi-center, open label, single-arm study to investigate the safety and efficacy of daily oral administration of 2 mg dienogest tablets for the treatment of endometriosis in adolescents over a treatment period of 52 weeks - Visanne Study to assess safety in adolescents

Phase 1

• Conditions: Clinically suspected or confirmed endometriosis in post menarche female adolescents; MedDRA version: 12.1Level: LLTClassification code 10014778Term: Endometriosis

• Registration Number: EUCTR2009-017169-53-FR
• Lead Sponsor: Bayer HelathCare AG, Leverkusen, D-51368 Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-14
• Study Completion: 2013-09-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 111

Inclusion Criteria

1. Female adolescents after menarche (12 – less than 18 years of age at screening)
2. Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:

clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs
OR:
any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal; only after additional specific consent and assent);
OR:
failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration after previous surgical confirmation of endometriosis)

3. Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks
4. Good general health (except for findings related to endometriosis, as evidenced by medical history, physical/ gynecological examination and laboratory tests)

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Absence of endometriosis at laparoscopy
2. Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment
3. Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)
4. Clinically established need for primary surgical treatment of endometriosis
5. Pregnancy or breast feeding
6. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
7. Diseases that may influence bone mineral density eg. anorexia, inflammatory bowel diseases (Crohn´s disease, ulcerative colitis) and celiac disease
8. Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
9. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
10. Undiagnosed abnormal genital bleeding
11. Amenorrhea (previous 3 months before screening)
12. Hypersensitivity to any ingredient of the study drug
13. Abuse of alcohol, drugs, or medicine (e.g. laxatives)
14. Clinically relevant findings at general physical or gynecological examination
15. Major surgery scheduled for the study period
16. Laboratory values outside inclusion range before allocation of treatment.
17. Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or might interfere with the conduct of the study or the interpretation of the results such as that described in Section 6.9

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate safety of dienogest (DNG) in the treatment of endometriosis in adolescents;Secondary Objective: To demonstrate efficacy of dienogest (DNG) in the treatment of endometriosis in adolescents;Primary end point(s): Change in BMD (spine scan) as measured by DEXA after 52 weeks of starting treatment.