Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508557960619 Date of Registration: 04/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized controlled trial of two different regimen in the treatment of unfavourable vaginjal bleeding in women on etonogestrel implant
Official scientific title A randomized controlled trial of two different regimen in the treatment of unfavourable vaginjal bleeding in women on etonogestrel implant
Brief summary describing the background and objectives of the trial The use of long-acting reversible contraceptives has been recommneded to significantly reduce unwanted pregnancies and its untwoard outcomes and in particular, maternal mortality and morbidity; a preventable scourge that still plagues low and middle income countries. These resource-poor settings have also been noted to have poor uptake of modern contraceptive methods and this is further worsened by accompanying poor continuation rates due to side-effects, especially menstrual side-effects. Etonogestrel subermal implants have been associated with menstrual side-effects which can remain persistent throughout duration of use. The management of these menstrual side-effects have remained controversial and the available long-term use of combined oral contraceptive to curb this pill negate te convenience and ease of a LARC. Its use is precluded in women in whom oestrogen is contraindicated. This study aims to assess the effect of combination of both mifepristone ( a progesterone modulator) and doxycycline ( matrix metalloproteinase inhibitor) on proloned and frequent vaginal bleeding in women using etonogestrel implants. The primary outcome measure is mean number of days to cessation of menstrual bleeding in these clients while other secondary outcome measures are proportion of women who stopped bleeding within one week of initiation of therapies and then side-effect profiles.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied management of menstrual side-effects following use of subdermal contraceptive implants
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2025
Actual trial start date
Anticipated date of last follow up 30/04/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group combined oral contraceptives 1 tablet daily 21 days desofem containing 0.15mg of desogestrel and 0.03mg of ethinyl estradiol 35 Active-Treatment of Control Group
Experimental Group mifepristone and doxycycline 50ug stat of mifepristone and then 100mg daily of doxycycline for 5 days 5 days of active drugs and remaining 16 days of placebo each client will use 50ug of mifepristone statim, then daily dose of 100mg of doxycycline for 5 days. this will be followed by 16 days of placebo 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Clients who have been on Etonogestrel subdermal implant with complaints of menstrual irregularities; prolonged or frequent bleeding. Pregnancy History of; •Venous thromboembolism, •Stroke, •Uncontrolled hypertension, •Coagulation disorder •Gynaecological cancer Known hypersensitivity to study drugs Current treatment with enzyme inducing drugs like phenytoin, carbamazepine, phenobarbital Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 04/08/2025 Ethical and Research Committee of the University of Benin Tecahinh Hospital
Ethics Committee Address
Street address City Postal code Country
ugbowo Benin 300283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean number of days to cessation of bleeding after completion of medications
Secondary Outcome proportion of women who stopped bleeding within one week of initiation of medications, side-effects profile A week after initaition of medications, then after use of medications
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
university of Benin teaching hospital ugbowo Benin city 300283 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ajayi Tejumade flat D5, Dentistry quarters, UBTH Benin 300283 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ajayi Tejumade Flat D5, Dentistry quarters, UBTH Benin 300283 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tejumade ajayi tejualice@gmail.com 08060191621 flat D5, dentistry quarters, university of benin teaching hospital.
City Postal code Country Position/Affiliation
benin city 300283 Nigeria senior registrar in department of obstetrics and gynaecology
Role Name Email Phone Street address
Scientific Enquiries tejumade ajayi tejualice@gmail.com 08060191621 flat d5, dentistry quarters, ubth
City Postal code Country Position/Affiliation
benin 300283 Nigeria senior registrar obstetrics and gynaecology
Role Name Email Phone Street address
Public Enquiries teju ajayi tejualice@gmail.com 08060191621 flat d5, dentistry quarters
City Postal code Country Position/Affiliation
Benin 300283 Nigeria senior registrar. dept of obstetrIcs and gynaecology UBTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained from this study may be provided to qualified researchers with interest in management of menstrual side-effects following insertion of etonogestrel subdermal implants. Data shared will be coded, with no PHI included. Approval of requests and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting parties. Informed Consent Form,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers involved in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 01/08/2025 correction by reviewer A RANDOMIZED CONTROLLED TRIAL OF TWO DIFFERENT REGIMENS IN THE TREATMENT OF UNFAVOURABLE VAGINAL BLEEDING IN WOMEN ON ETONOGESTREL IMPLANT. A randomized controlled trial of two different regimen in the treatment of unfavourable vaginjal bleeding in women on etonogestrel implant
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 01/08/2025 reviewer's correction A RANDOMIZED CONTROLLED TRIAL OF TWO DIFFERENT REGIMENS IN THE TREATMENT OF UNFAVOURABLE VAGINAL BLEEDING IN WOMEN ON ETONOGESTREL IMPLANT. A randomized controlled trial of two different regimen in the treatment of unfavourable vaginjal bleeding in women on etonogestrel implant
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 01/08/2025 reviewer's correction this is a non-inferiority RCT involving use of mifepristone/doxycyline combination versus standard therapy of combined oral contraceptive pills in the management of frequent and prolonged menstrual bleeding in clients who opt for etonogestrel subdermal implants. The primary outcome measure is mean number of days to cessation of menstrual bleeding in these clients while other secondary outcome measures are proportion of women who stopped bleeding within one week of initiation of therapies and then side-effect profiles. The use of long-acting reversible contraceptives has been recommneded to significantly reduce unwanted pregnancies and its untwoard outcomes and in particular, maternal mortality and morbidity; a preventable scourge that still plagues low and middle income countries. These resource-poor settings have also been noted to have poor uptake of modern contraceptive methods and this is further worsened by accompanying poor continuation rates due to side-effects, especially menstrual side-effects. Etonogestrel subermal implants have been associated with menstrual side-effects which can remain persistent throughout duration of use. The management of these menstrual side-effects have remained controversial and the available long-term use of combined oral contraceptive to curb this pill negate te convenience and ease of a LARC. Its use is precluded in women in whom oestrogen is contraindicated. This study aims to assess the effect of combination of both mifepristone ( a progesterone modulator) and doxycycline ( matrix metalloproteinase inhibitor) on proloned and frequent vaginal bleeding in women using etonogestrel implants. The primary outcome measure is mean number of days to cessation of menstrual bleeding in these clients while other secondary outcome measures are proportion of women who stopped bleeding within one week of initiation of therapies and then side-effect profiles.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/08/2025 Reviewer's correction FALSE, Ethical and Research Committee of the University of Benin Tecahinh Hospital, flat D5, Dentistry quartersm UBTH, Benin, 300283, Nigeria, 01 Aug 2025, , 08060191621, tejualice@gmail.com, FALSE, Ethical and Research Committee of the University of Benin Tecahinh Hospital, ugbowo, Benin, 300283, Nigeria, 04 Aug 2025, , 07063331337, Ubthresearchethics@gmail.com,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 01/08/2025 reviewer's correction an excel sheet showing demographics, pattern of menses before and after intervention, summary of results and conclusion Data obtained from this study may be provided to qualified researchers with interest in management of menstrual side-effects following insertion of etonogestrel subdermal implants. Data shared will be coded, with no PHI included. Approval of requests and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting parties.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 01/08/2025 reviewer's correction 1 year Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 01/08/2025 reviewer's correction open access Access to trial IPD can be requested by qualified researchers involved in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 01/08/2025 reviewer's correction Study Protocol, Statistical Analysis Plan, Informed Consent Form Study Protocol, Informed Consent Form