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History of Changes for Study: NCT02103764
Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB (SI-AUB-RCT)
Latest version (submitted August 20, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 1, 2014 None (earliest Version on record)
2 April 15, 2014 Study Status and Study Identification
3 July 4, 2015 Study Status
4 August 20, 2018 Recruitment Status, Study Status, Contacts/Locations and Outcome Measures
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Study NCT02103764
Submitted Date:  July 4, 2015 (v3)

Open or close this module Study Identification
Unique Protocol ID: DSG-SIAUB
Brief Title: Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB (SI-AUB-RCT)
Official Title: The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2015
Overall Status: Recruiting
Study Start: August 2013
Primary Completion: December 2015 [Anticipated]
Study Completion: December 2015 [Anticipated]
First Submitted: February 18, 2014
First Submitted that
Met QC Criteria:
April 1, 2014
First Posted: April 4, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 4, 2015
Last Update Posted: July 7, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Mahidol University
Responsible Party: Principal Investigator
Investigator: Manee Rattanachaiyanont
Official Title: Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital
Affiliation: Mahidol University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The objectives of the present study is to determine the effectiveness of cyclic desogestrel (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory dysfunctional uterine bleeding (DUB) in the following aspects:

  1. Endometrial histopathology changes
  2. Menstrual cycle control.
Detailed Description:

Anovulatory dysfunctional uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding especially in postmenarcheal adolescent, perimenopausal women, patient with polycystic ovary syndrome (PCOS) and in obese women. Aims of treatment in women with anovulatory DUB are to restore the natural control mechanism of endometrium (introduce normal synchronous growth, development, shedding of a structural stable endometrium) and to prevent endometrial hyperplasia. The two main treatment options are estrogen-progestin therapy and progestin therapy. Women who are sexually active and not immediately prepared to pursue pregnancy are best manage by estrogen-progestin treatment especially combined oral contraceptive pills (COCs) but in perimenopausal women, obese women or women who can't tolerate COCs or have contraindications in using COCs, cyclic progestin will be the treatment of choice. Common used progestin in anovulatory DUB is medroxyprogesterone acetate (MPA) 5-10 mg/day for 10-14 days each month. This progestin has strong progestogenic effect but has some undesirable effect such as glucocorticoid effect, mineralocorticoid effect and androgenic effect. Long term using this progestin especially in obese women or perimenopausal women who have risk for diabetes mellitus and dyslipidemia may be negative effect to glucose and lipid metabolism. DSG is the third generation progestin with no glucocorticoid, mineralocorticoid effect and low androgenic effect may be the better choice of treatment but the data of DSG in treatment of anovulatory DUB us scanty. So this study will evaluate the effect of cyclic DSG in endometrial histology changing and lipid, glucose metabolism in patient with anovulatory DUB.

Comparison : Women with anovulatory DUB are randomized into two groups, receiving a course of either cyclic DSG or cyclic MPA. The main outcome measured is to compare the effect of both interventions on endometrial histology changing.

Open or close this module Conditions
Conditions: Dysfunctional Uterine Bleeding
Keywords: Anovulatory Dysfunctional Uterine Bleeding
cyclic desogestrel
cyclic medroxyprogesterone acetate
lipid metabolism
glucose metabolism
endometrial histology changing
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 160 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Desogestrel
Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month
Drug: Desogestrel
Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month
Other Names:
  • Cerazette
Active Comparator: Medroxyprogesterone acetate
Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month
Drug: Medroxyprogesterone acetate
Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month
Other Names:
  • Provera
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The change in endometrial histology
The participants are evaluated for changing of endometrial histology at day 8 or 9 or 10 of treatment period.

[Time Frame: Baseline, Day 8 or 9 or 10 of treatment period in first month]
Secondary Outcome Measures:
2. The occurrence of withdrawal bleeding
To compare the occurrence of withdrawal bleeding between cyclic DSG and cyclic MPA after taking each groups.

[Time Frame: 6 months]
3. Effect of cyclic DSG on lipid metabolism compared with cyclic MPA
6 months
4. Effect of cyclic DSG on glucose metabolism compared with cyclic MPA
6 months
5. Adverse events
At day 8 or 9 or 10 of the first cycle and 3, 6 month
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Premenopausal women with anovular DUB (proved by endometrial histology)
  • Age > 18 yr.

Exclusion Criteria:

  • Any uterine pathology that might cause abnormal uterine bleeding
  • Contraindication to progestin treatment (such as breast cancer)
  • Severe drug allergy towards a progestogen
  • Intake of any hormonal treatment in the previous 3 months
Open or close this module Contacts/Locations
Central Contact Person: Manee Rattanachaiyanont, M.D.
Telephone: +66-2419-4657
Email: manee.rat@mahidol.ac.th
Central Contact Backup: Nisarath Soontrapa, M.D.
Telephone: +66-8-7936-6457
Email: pui_pika@hotmail.com
Study Officials: Manee Rattanachaiyanont, M.D.
Principal Investigator
Mahidol University
Locations: Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
[Recruiting]
Bangkok, Thailand, 10700
Contact:Contact: Manee Rattanachaiyanont, M.D. +66-2419-4657 manee.rat@mahidol.ac.th
Contact:Contact: Nisarath Soontrapa, M.D. +66879366457 pui_pika@hotmail.com
Contact:Principal Investigator: Manee Rattanachaiyanont, M.D.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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