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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclofem group | Experimental | Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose |
|
| Placebo group | Placebo Comparator | normal saline 0.5 ml IM single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclofem | Drug | Intramuscularly injection 0.5 ml of Cyclofem or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo | Menstrual record chart was using to record bleeding/spotting days | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users |
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Inclusion Criteria:
Exclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitisa Tapanwong, MD | Contact | 066817931684 | nitisa.tapanwong@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nitisa Tapanwong, MD | Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn Hospital | Recruiting | Bangkok | Thailand |
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| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C034528 | CycloProvera |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Questionnaire was using to record adverse effect during follow up period |
| 12 weeks |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |