Visanne Study to Assess Safety in Adolescents (VISADO)

Bayer

Status and phase: Completed; Phase 2

Conditions: Endometriosis

Treatments: Drug: Dienogest (Visanne, BAY86-5258)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01283724

13788

2009-017169-53 (EudraCT Number)

Details and patient eligibility

About

A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.

Enrollment: 111 patients

Sex: Female

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female adolescents after menarche (12 - less than 18 years of age) at screening. For Finland: Adolescents aged 12 - 14 years old who present with clinical features of endometriosis will only be enrolled into the study if their diagnosis of endometriosis has been confirmed by laparoscopy.

• 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 and/or oral contraceptives
  • Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal; only after additional specific consent and assent)
  • Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)
  • 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

Exclusion criteria

• Absence of endometriosis at laparoscopy
• 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
• 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)
• Clinically established need for primary surgical treatment of endometriosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

Dienogest (Visanne, BAY86-5258)

Experimental group

Description:

Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.

Treatment:

Drug: Dienogest (Visanne, BAY86-5258)