Uterine BleedingPhase 1/2NCT03264781
The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users
A Phase 1/2 study testing Cyclofem in people with Uterine Bleeding, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Bleeding
- What is being tested?
- Cyclofem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2016to Dec 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Allergic to drug component of Cyclofem® ( Medroxyprogesterone acetate , Estradiol cypionate)
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn Hospital
Bangkok
Nitisa Tapanwong, MD, nitisa.tapanwong@gmail.com
About this study
Official title: The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users; a Randomized Controlled Trial
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.
Read the detailed description
Stratified randomization Implanon and Jadelle group were done using block randomization. The participants and investigators were blinded to treatment allocation, using drug coding that not revealed until the end of study. Research assistants and nurse who did not have involve in analyses data would follow the recruitment criteria and drug injection follow the code of drug.
All participants were collected demographic data, medical history, obstetrical and gynecological history, bleeding pattern before enrollment. Then physical exam and pelvic examination were performed for all participants. Participants received single dose intramuscular injection of Cyclofem® 0.5 ml or normal saline 0.5 ml as placebo on that day of recruitment to the study. Daily record of bleeding, spotting and side effect was done on record form.
- Conditions
- Uterine Bleeding
- Being tested
- Cyclofem
- Keywords
- Cyclofem®, Implant, Jadelle, Implanon, irregular uterine bleeding, randomized controlled trial
- Medical subject headings
- Uterine Hemorrhage, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclofemDrug
Also called Questionnaire and Menstrual record chart
Intramuscularly injection 0.5 ml of Cyclofem or placebo
| Study group | Role | What they receive |
|---|---|---|
| Cyclofem group | Experimental | Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose Receives: Drug: Cyclofem |
| Placebo group | Placebo comparator | normal saline 0.5 ml IM single dose Receives: Drug: Cyclofem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
Menstrual record chart was using to record bleeding/spotting days
Measured: 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
Menstrual record chart was using to record bleeding/spotting days
Measured: 12 weeks
Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users
Questionnaire was using to record adverse effect during follow up period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitisa Tapanwong, MD, Principal investigator, Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264781
- Sponsor's protocol ID
- OBCU
- Status last verified
- Aug 2017
- First submitted
- 6 Jun 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03264781
- Acronym / sponsor ID
- OBCU
- Conditions
- Uterine Bleeding
- Keywords
- Cyclofem®, Implant, Jadelle, Implanon, irregular uterine bleeding, randomized controlled trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stratified randomization Implanon and Jadelle group were done using block randomization. The participants and investigators were blinded to treatment allocation, using drug coding that not revealed until the end of study. Research assistants and nurse who did not have involve in analyses data would follow the recruitment criteria and drug injection follow the code of drug.
All participants were collected demographic data, medical history, obstetrical and gynecological history, bleeding pattern before enrollment. Then physical exam and pelvic examination were performed for all participants. Participants received single dose intramuscular injection of Cyclofem® 0.5 ml or normal saline 0.5 ml as placebo on that day of recruitment to the study. Daily record of bleeding, spotting and side effect was done on record form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclofem group | Experimental | Drug: CyclofemMedroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose |
| Placebo group | Placebo comparator | Drug: Cyclofemnormal saline 0.5 ml IM single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Contraindication to estrogen or progesterone use such as
- Previous treatment for 3 months before enrollment
- Allergic to drug component of Cyclofem® ( Medroxyprogesterone acetate , Estradiol cypionate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclofemAlso: Questionnaire and Menstrual record chartIntramuscularly injection 0.5 ml of Cyclofem or placebo | Drug | Cyclofem group, Placebo group |
Primary outcome
Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
Time frame: 12 weeks
Menstrual record chart was using to record bleeding/spotting days
2 secondary outcomes
Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users
Time frame: 12 weeks
Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitisa Tapanwong, MD principal investigator
Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclofem in people with Uterine Bleeding, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitisa Tapanwong, MD (066817931684, nitisa.tapanwong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.