Skip to main content
OpenTrials
Completed

NCT Number: NCT01767090

A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

The main objective for this study is to assess the efficacy and dose-response relationship of ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to assess the safety, tolerability, Pharmacokinetics of ASP1707, dose response relationship of ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of endometriosis associated pain and 24-week safety and tolerability of ASP1707.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Site: 1006, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pre menopausal female adults with confirmed length and regular menstrual cycle
  • Surgically diagnosed endometriosis
  • Moderate to severe endometriosis related pain

Exclusion criteria

  • Hormonal contraceptives or other drugs with effects on gynecological endocrinology
  • Surgery for endometriosis within the 4 weeks prior to entry
  • Uterine myoma
  • Abnormal vaginal bleeding
  • Hysterectomy or bilateral oophorectomy
  • Pelvic infection
  • Relevant abnormalities at gynecological exam at screening
  • Disease with chronic abdominal pain of non-endometriosis origin
  • Pituitary adenoma

Treatment and study plan

ASP1707

Drug

Oral

Placebo

Drug

Oral

Leuprorelin Acetate

Drug

subcutaneous

Other names: Prostap® SR

Primary outcomes

  1. Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain

    Time frame: Baseline & Week 12

  2. Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea

    Time frame: Baseline & Week 12

  3. Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain

    Time frame: Baseline & Week 12

Secondary outcomes

  1. Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain

    Time frame: Baseline & Week 24

  2. Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea

    Time frame: Baseline & Week 24

  3. Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain

    Time frame: Baseline & Week 24

  4. Change from baseline to the end of treatment (EoT) of the dyspareunia score

    Time frame: Baseline, Week 12 & Week 24

  5. Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia

    Time frame: Week 12 & Week 24

  6. Change from baseline to the EoT of the mean scores of the modified Biberoglu and Behrman (B&B) symptom and sign domains

    Time frame: Baseline, Week 12 & Week 24

  7. Change from baseline to the EoT of the use of protocol defined rescue medication

    Time frame: Baseline, Week 12 & Week 24

  8. Change from baseline to the EoT of the mean Pain Interference score of the Brief Pain Inventory

    Time frame: Baseline, Week 12 & Week 24

  9. Patient Global Impression of Change (PGIC) at the End of Treatment

    Time frame: Week 12 & Week 24

  10. Change from baseline to the EoT in the Endometriosis Health Profile (EHP)-5 score

    Time frame: Baseline, Week 12 & Week 24

  11. Change from baseline to the EoT of the Female Sexual Function Index (FSFI) score (sexual well-being)

    Time frame: Baseline, Week 12 & Week 24

  12. Change from baseline to the EoT of the Beck's Depression Inventory (BDI)-II score

    Time frame: Baseline, Week 12 & Week 24

  13. Change from baseline to the EoT in the EuroQol (EQ-5D-5L) score

    Time frame: Baseline, Week 12 & Week 24

  14. Safety and tolerability of ASP1707 measured by Adverse Events (AEs), bleeding patterns, Bone Mineral Density (BMD)

    Time frame: Up to Week 42

  15. Pharmacodynamic profile of ASP1707 measured by Serum Estradiol (E2) levels

    Time frame: Up to Week 26

  16. Pharmacokinetic profile of ASP1707

    Time frame: Up to Week 24

    Both CL/F, V/F, AUCtau, Cmax, Ctrough

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Dose-Response Relationship of ASP1707 in Subjects With Endometriosis Associated Pelvic Pain for 12 Weeks, Followed by a 12-Week Double-blind Extension Without Placebo Control, Including a 24-Week Open-Label Leuprorelin Acetate Treatment Group for Bone Mineral Density Assessment

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2013
Registry last updated
Oct 23, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.