NCT03264781

Brief Summary

The purpose of this study is to determine that once-a-month injectable contraceptive( Cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant contraceptive users or not.

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
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

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, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

June 6, 2017

Last Update Submit

August 29, 2017

Conditions

Uterine Bleeding

Keywords

Cyclofem®ImplantJadelleImplanonirregular uterine bleedingrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo

    Menstrual record chart was using to record bleeding/spotting days

    12 weeks

Secondary Outcomes (2)

  • Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users

    12 weeks

  • Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users

    12 weeks

Study Arms (2)

Cyclofem group

EXPERIMENTAL

Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose

Drug: Cyclofem

Placebo group

PLACEBO COMPARATOR

normal saline 0.5 ml IM single dose

Drug: Cyclofem

Interventions

CyclofemDRUG

Intramuscularly injection 0.5 ml of Cyclofem or placebo

Also known as: Questionnaire and Menstrual record chart
Cyclofem groupPlacebo group

Eligibility Criteria

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

You may qualify if:

  • Implant (Jadelle or Implanon) inserted before enrollment with the symptom of bleeding disturbances for eight or more continuous days or a current bleeding-free interval of 15 days or less
  • Regular menstruation at least 1 cycle before the usage of implant contraceptive
  • Willingness to participate in a placebo-controlled study and ability to keep an accurate daily menstrual record
  • No gynecological or serious medical diseases

You may not qualify if:

  • Contraindication to estrogen or progesterone use such as
  • breast cancer
  • Liver cancer or tumor
  • Uncontrolled blood pressure (BP ≥160/100 mmHg )
  • History of atherosclerosis, vascular disease and high risk for VIE
  • History of ischemic stroke
  • Coagulopathy
  • Uncontrolled diabetes mellitus and complication
  • Cirrhosis
  • SLE with antiphospholipid positive
  • History of migraine with aura or age of 35 years old or more than with history of migraine non-aura
  • Age of 35 years old or more than with history of smoking more than 15 cigarettes per day
  • Postpartum 6 weeks
  • Plan for surgery procedure that need immobilization after surgery
  • Previous treatment for 3 months before enrollment
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn Hospital

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Uterine HemorrhageMenstruation Disturbances

Interventions

CycloProveraSurveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nitisa Tapanwong, MD

    Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitisa Tapanwong, MD

CONTACT

066817931684nitisa.tapanwong@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

August 29, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 30, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)