Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04233632
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2020-01-14
Brief Title:
Comparative Study of the Contraceptive Efficacy of the Cupid Cupid 2 and FC2 Female Condom
Sponsor:
Prof Mags Beksinska
Organization:
University of Witwatersrand South Africa
Study Overview
Official Title:
Randomized Comparative Study of the Contraceptive Efficacy of the Cupid Cupid 2 and FC2 Female Condom
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study aims to assess the effectiveness of three female condoms Cupid Cupid 2 and Female Condom 2FC2 for the prevention of pregnancy among women choosing the female condom FC as their method of fertility regulation Participants will be followed-up monthly for up to seven months A daily diary will be used to record menstrual pattern acts of intercourse and details of condom usage
Detailed Description:
This research study aims to assess the effectiveness of three female condoms Cupid Cupid 2 and FC2 for the prevention of pregnancy among women choosing the female condom FC as their method of fertility regulation
The study is a randomized comparative prospective follow-up study Participants will be followed-up monthly for up to seven months A daily diary will be used to record menstrual pattern acts of intercourse and details of condom usage The primary endpoint will be the occurrence of pregnancy or use of emergency contraception and the diary information will allow pregnancy rates to be characterized by patterns of condom use and failures contraceptive efficacy and effectiveness rates
The target population will be 780 urban and peri urban sexually active women who are experienced users of FCs Recruitment will be from a family planning clinic associated with the MatCH Research Unit MRU University of the Witwatersrand Durban South Africa and the surrounding community The woman rather than the couple will be the unit of observation since the major outcome to be measured is pregnancy There will be monthly follow-ups of participants from enrollment until after the 6th menstrual cycle month 12345 and 6 All visits will be conducted at the research site The diary to be completed on a daily basis by the participants will indicate whether the coital frequency differs significantly between subgroups students urban peri-urban
Female clients of the Commercial City Clinic and other women presenting at the site will be informed about the study If a potential participant expresses interest in participating she will be given the study information sheet to read which will describe the study requirements and her potential role in the study If she agrees to take part in the research she will be asked to provide written informed consent The participant will be administered the screening form to determine whether she meets study inclusion criteria
Eligible women who agree to participate will undergo a baseline interview Information collected during the enrollment interview will include demographic data and information on the participants general and reproductive health The data collected on reproductive health variables will include the date of last menstrual period LMP history of pregnancies births and miscarriages a contraceptive history as well as a sexual history After completion of the interview the participant will be randomized to the use on one FC type
Male partners will not be asked to sign an Informed Consent as they will not be required to participate in the research but female participants will be given an additional information sheet if they desire to give to the male partner to tell them about the study
If a potential participant does not wish to be enrolled she will be provided with referral should she wish for any reproductive health services according to normal clinical practice at the study site Her reasons will be recorded on the log of refusals This information will be used to compile statistics on the participation rates and reasons for nonparticipation
Although all study participants are required to have ever used a FC some may have not used the FC they have been randomized to and have experience with other FC types All participants will be retrained regardless of previous FC use using a pelvic model The study staff will demonstrate FC insertion and train the participants in the proper use of the randomized FC type Further they will provide instruction on how to complete the condom use log and the study diary She will also receive instructions on use in her preferred language English or Zulu
The participants will be given their first study packet which will contain either Cupid Cupid 2 or FC2 with a diary for the first month of the study Research staff will discuss with the participant how many condoms they require for the month The participants will be instructed how to complete the diary card The first follow-up visit should occur approximately one month after enrollment and should be pre-scheduled The date of the first follow-up visit should be written in an appointment card and on the designated location on the Condom diary card Participants who finish using their condoms prior to their scheduled follow-up visit will be encouraged to contact MRU for a resupply
There will be six follow-up visits in person at 1 2 3 4 5 and 6 months Telephonic follow-up will be conducted between 7-14 days post enrollment to confirm any queries or problems in use of condoms or diaries
Participants will be administered a follow-up survey about their experiences using their randomized FC whether there has been a delay in expected onset of menses the date of last menstrual period and information on the use of other contraceptives since the last visit The daily diary will also be reviewed at each visit for completeness and accuracy A pregnancy test will be carried out at every on-site visit Any reported or confirmed pregnancies will include counseling and referral to an antenatal or other healthcare facility The final follow up visit will be scheduled after 6th menstrual cycle
Women will be discontinued from the study at any stage during follow-up for pregnancy unwillingness to continue use of FCs or change to a non-study contraceptive method as her main contraceptive method or refusal to be followed up
Block randomization will be used A statistician not otherwise involved in this study will develop the random allocation sequence using a validated statistical program in Stata StataCorp LP College Station Texas USA Use-order assignments will be generated via the RedCap electronic program The statistician will be blinded until all data have been captured and the primary analysis programs have been verified Due to dissimilarities of the study products it will not be possible to blind participants and clinic staff associated with the project
The study is a randomized comparative prospective follow-up study Participants will be followed-up monthly for up to seven months A daily diary will be used to record menstrual pattern acts of intercourse and details of condom usage The primary endpoint will be the occurrence of pregnancy or use of emergency contraception and the diary information will allow pregnancy rates to be characterized by patterns of condom use and failures contraceptive efficacy and effectiveness rates
The target population will be 780 urban and peri urban sexually active women who are experienced users of FCs Recruitment will be from a family planning clinic associated with the MatCH Research Unit MRU University of the Witwatersrand Durban South Africa and the surrounding community The woman rather than the couple will be the unit of observation since the major outcome to be measured is pregnancy There will be monthly follow-ups of participants from enrollment until after the 6th menstrual cycle month 12345 and 6 All visits will be conducted at the research site The diary to be completed on a daily basis by the participants will indicate whether the coital frequency differs significantly between subgroups students urban peri-urban
Female clients of the Commercial City Clinic and other women presenting at the site will be informed about the study If a potential participant expresses interest in participating she will be given the study information sheet to read which will describe the study requirements and her potential role in the study If she agrees to take part in the research she will be asked to provide written informed consent The participant will be administered the screening form to determine whether she meets study inclusion criteria
Eligible women who agree to participate will undergo a baseline interview Information collected during the enrollment interview will include demographic data and information on the participants general and reproductive health The data collected on reproductive health variables will include the date of last menstrual period LMP history of pregnancies births and miscarriages a contraceptive history as well as a sexual history After completion of the interview the participant will be randomized to the use on one FC type
Male partners will not be asked to sign an Informed Consent as they will not be required to participate in the research but female participants will be given an additional information sheet if they desire to give to the male partner to tell them about the study
If a potential participant does not wish to be enrolled she will be provided with referral should she wish for any reproductive health services according to normal clinical practice at the study site Her reasons will be recorded on the log of refusals This information will be used to compile statistics on the participation rates and reasons for nonparticipation
Although all study participants are required to have ever used a FC some may have not used the FC they have been randomized to and have experience with other FC types All participants will be retrained regardless of previous FC use using a pelvic model The study staff will demonstrate FC insertion and train the participants in the proper use of the randomized FC type Further they will provide instruction on how to complete the condom use log and the study diary She will also receive instructions on use in her preferred language English or Zulu
The participants will be given their first study packet which will contain either Cupid Cupid 2 or FC2 with a diary for the first month of the study Research staff will discuss with the participant how many condoms they require for the month The participants will be instructed how to complete the diary card The first follow-up visit should occur approximately one month after enrollment and should be pre-scheduled The date of the first follow-up visit should be written in an appointment card and on the designated location on the Condom diary card Participants who finish using their condoms prior to their scheduled follow-up visit will be encouraged to contact MRU for a resupply
There will be six follow-up visits in person at 1 2 3 4 5 and 6 months Telephonic follow-up will be conducted between 7-14 days post enrollment to confirm any queries or problems in use of condoms or diaries
Participants will be administered a follow-up survey about their experiences using their randomized FC whether there has been a delay in expected onset of menses the date of last menstrual period and information on the use of other contraceptives since the last visit The daily diary will also be reviewed at each visit for completeness and accuracy A pregnancy test will be carried out at every on-site visit Any reported or confirmed pregnancies will include counseling and referral to an antenatal or other healthcare facility The final follow up visit will be scheduled after 6th menstrual cycle
Women will be discontinued from the study at any stage during follow-up for pregnancy unwillingness to continue use of FCs or change to a non-study contraceptive method as her main contraceptive method or refusal to be followed up
Block randomization will be used A statistician not otherwise involved in this study will develop the random allocation sequence using a validated statistical program in Stata StataCorp LP College Station Texas USA Use-order assignments will be generated via the RedCap electronic program The statistician will be blinded until all data have been captured and the primary analysis programs have been verified Due to dissimilarities of the study products it will not be possible to blind participants and clinic staff associated with the project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None