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Trial record 18 of 25 for:    gestodene

Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain

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ClinicalTrials.gov Identifier: NCT01056042
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Sopon Cheewadhanaraks, Prince of Songkla University

Tracking Information
First Submitted Date  ICMJE January 25, 2010
First Posted Date  ICMJE January 26, 2010
Last Update Posted Date October 29, 2014
Study Start Date  ICMJE June 2007
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Patients' satisfaction with the treatment [ Time Frame: 1 year and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01056042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
pain reduction and adverse side effects [ Time Frame: 1 year and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
Official Title  ICMJE Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.
Brief Summary Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In the second group patients have oral contraceptive combined pills everyday for 6 months. Patients are followed up on recurrence of pain for 1 year after medication.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: intramuscular depot medroxyprogesterone acetate
    150 mg, Intramuscular, every 3 months
    Other Name: Depo Provera
  • Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms
    one tablet orally, everyday
    Other Name: Gynera
Study Arms  ICMJE
  • Experimental: A
    Intramuscular depot medroxyprogesterone acetate
    Intervention: Drug: intramuscular depot medroxyprogesterone acetate
  • Active Comparator: B
    ethinyl estradiol 30 micrograms combined with gestodene 75 micrograms
    Intervention: Drug: ethinyl estradiol 30 micrograms, gestodene 75 micrograms
Publications * Vercellini P, Frontino G, De Giorgi O, Pietropaolo G, Pasin R, Crosignani PG. Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen. Fertil Steril. 2003 Sep;80(3):560-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 25, 2010)
112
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.

Exclusion Criteria:

  • Medical therapies for endometriosis other than NSAID within previous 6 months
  • Contraindication to the drugs
  • Wish to conceive
  • Request for extirpative surgery
  • Other pelvic pathology ( adenomyosis, chronic PID, submucous myoma uteri )
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01056042
Other Study ID Numbers  ICMJE EC 50/370-029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sopon Cheewadhanaraks, Prince of Songkla University
Study Sponsor  ICMJE Prince of Songkla University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sopon Cheewadhanaraks, M.D. Faculty of Medicine, Prince of Songkla University
PRS Account Prince of Songkla University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP