NCT02103764

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. 1.Endometrial histopathology changes
  2. 2.Menstrual cycle control.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

4.9 years

First QC Date

February 18, 2014

Last Update Submit

August 20, 2018

Conditions

Dysfunctional Uterine Bleeding

Keywords

Anovulatory Dysfunctional Uterine Bleedingcyclic desogestrelcyclic medroxyprogesterone acetatelipid metabolismglucose metabolismendometrial histology changing

Outcome Measures

Primary Outcomes (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.

    Baseline, Day 8 or 9 or 10 of treatment period in first month

Secondary Outcomes (4)

  • The occurrence of withdrawal bleeding

    6 months

  • Effect of cyclic DSG on lipid metabolism compared with cyclic MPA

    6 months

  • Effect of cyclic DSG on glucose metabolism compared with cyclic MPA

    6 months

  • Adverse events

    At day 8 or 9 or 10 of the first cycle and 3, 6 month

Study Arms (2)

Desogestrel

EXPERIMENTAL

Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month

Drug: Desogestrel

Medroxyprogesterone acetate

ACTIVE COMPARATOR

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

Interventions

DesogestrelDRUG

Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month

Also known as: Cerazette
Desogestrel
Medroxyprogesterone acetateDRUG

Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month

Also known as: Provera
Medroxyprogesterone acetate

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Soontrapa N, Rattanachaiyanont M, Warnnissorn M, Wongwananuruk T, Indhavivadhana S, Tanmahasamut P, Techatraisak K, Angsuwathana S. The effectiveness of desogestrel for endometrial protection in women with abnormal uterine bleeding-ovulatory dysfunction: a non-inferiority randomized controlled trial. Sci Rep. 2022 Jan 31;12(1):1662. doi: 10.1038/s41598-022-05578-0.

    PMID: 35102226DERIVED

MeSH Terms

Conditions

Metrorrhagia

Interventions

DesogestrelMedroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanes

Study Officials

  • Manee Rattanachaiyanont, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Study Record Dates

First Submitted

February 18, 2014

First Posted

April 4, 2014

Study Start

August 1, 2013

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations

TH(1)