JRCT ID: jRCT2011210027
Registered date:06/08/2021
A study of FSN-013 in Japanese patients with endometriosis
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | endometriosis |
Date of first enrollment | 02/08/2021 |
Target sample size | 150 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Each subject will receive one tablet of FSN-013(Estetrol Hydrate/Drospirenone) or Placebo orally once a day. |
Outcome(s)
Primary Outcome | The amount of change in the most severe pelvic pain (lower abdominal pain / back pain) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Female |
Include criteria | 1.Diagnosed as endometriosis by laparotomy or laparoscopy 2.Diagnosed as endometriosis (having ovarian chocolate cysts) by TVUS or MRI 3.Patients clinically diagnosed as endometriosis with any of Douglas fossa induration or limited uterine mobility or pelvic tenderness by vaginal or rectal examination 4.Aged >= 20 years at the time of informed consent 5.BMI < 30 kg/m2 |
Exclude criteria | 1.Unconfirmed diagnosis of abnormal vaginal bleeding within 6 months before the screening tests 2.Aged >= 40 years with ovarian chocolate cysts for which the largest diameter was > 10 cm 3.Ovarian chocolate cysts containing solid components 4.Had undergone surgical treatment for endometriosis, adenomyosis and uterine fibroids by cyst puncture (such as transvaginal alcohol fixation), laparotomy or laparoscopy within 2 months before screening |
Related Information
Primary Sponsor | Takayanagi Toshiaki |
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Secondary Sponsor | |
Source(s) of Monetary Support | M3, Inc. |
Secondary ID(s) |
Contact
Public contact | |
Name | Toshiaki Takayanagi |
Address | 5-7 Sanban-cho, Chiyoda-ku, Tokyo Tokyo Japan 102-0075 |
Telephone | +81-3-3556-3344 |
clinical_trials@fujipharma.jp | |
Affiliation | Fuji Pharma Co., Ltd. |
Scientific contact | |
Name | Toshiaki Takayanagi |
Address | 5-7 Sanban-cho, Chiyoda-ku, Tokyo Tokyo Japan 102-0075 |
Telephone | +81-3-3556-3344 |
clinical_trials@fujipharma.jp | |
Affiliation | Fuji Pharma Co., Ltd. |