Trial Outcomes & Findings for Rectal Microbicide Acceptability, Tolerability and Adherence (NCT NCT03671239)

Last Updated: 2023-01-20

Results Overview

Using a 10-point scale (1=Very Unlikely; 10=Very Likely), participants were asked to answer the following question about their most recently used product: "Think about the positive and negative experiences you have had using the \[study product\] during the past 4-week period. If this \[study product\] was available and it provided some protection against HIV, how likely would you be to use it before receptive anal sex?". The endpoint was operationalized as binary, with scores 1 to 6 grouped as "low acceptability" and scores 7 to 10 as "high acceptability".

Recruitment status

COMPLETED

Study phase

Target enrollment

217 participants

Primary outcome timeframe

14 weeks (three 4-week product use periods with 1-week washout periods between them)

Results posted on

2023-01-20

Participant Flow

Recruitment took place at seven clinical research sites in four countries from April 2019 to March 2020

Participant milestones

Participant milestones
Measure	Product Sequence A Participants will use placebo rectal inserts during the first 4-week product use period, placebo rectal douches during the second 4-week product use period, and placebo rectal suppositories during the third and final 4-week product use period. Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Product Sequence B Participants will use placebo rectal douches during the first 4-week product use period, placebo rectal suppositories during the second 4-week product use period, and placebo rectal inserts during the third and final 4-week product use period. Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Product Sequence C Participants will use rectal suppositories during the first 4-week product use period, rectal inserts during the second 4-week product use period, and rectal douches during the third and final 4-week product use period. Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Product Sequence D Participants will use placebo rectal inserts during the first 4-week product use period, placebo rectal suppositories during the second 4-week product use period, and placebo rectal douches during the third and final 4-week product use period. Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Product Sequence E Participants will use placebo rectal douches during the first 4-week product use period, placebo rectal inserts during the second 4-week product use period, and placebo rectal suppositories during the third and final 4-week product use period. Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.	Product Sequence F Participants will use placebo rectal suppositories during the first 4-week product use period, placebo rectal douches during the second 4-week product use period, and placebo rectal inserts during the third and final 4-week product use period. Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI. Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
First Intervention (4 Weeks) STARTED	35	36	37	36	37	36
First Intervention (4 Weeks) COMPLETED	33	33	35	35	35	33
First Intervention (4 Weeks) NOT COMPLETED	2	3	2	1	2	3
Washout (1 Week) STARTED	35	36	37	36	37	36
Washout (1 Week) COMPLETED	35	36	37	36	37	36
Washout (1 Week) NOT COMPLETED	0	0	0	0	0	0
Second Intervetion (4 Weeks) STARTED	35	36	37	36	37	36
Second Intervetion (4 Weeks) COMPLETED	33	33	37	34	34	35
Second Intervetion (4 Weeks) NOT COMPLETED	2	3	0	2	3	1
Third Intervention (4 Weeks) STARTED	35	36	37	36	37	36
Third Intervention (4 Weeks) COMPLETED	33	35	35	34	36	34
Third Intervention (4 Weeks) NOT COMPLETED	2	1	2	2	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only participants at the U.S. sites

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=217 Participants All study participants used rectal inserts, rectal douches, or rectal suppositories, each for a 4-week period, in six different sequencies (A-F) and were instructed to use their assigned study product prior to each RAI encounter during that period.
Age, Continuous	24.9 years STANDARD_DEVIATION 4.7 • n=217 Participants
Sex/Gender, Customized Male	173 Participants n=217 Participants
Sex/Gender, Customized Female	2 Participants n=217 Participants
Sex/Gender, Customized Transgender Male	2 Participants n=217 Participants
Sex/Gender, Customized Transgender Female	19 Participants n=217 Participants
Sex/Gender, Customized Gender nonconforming/Variant	5 Participants n=217 Participants
Sex/Gender, Customized Other Gender	10 Participants n=217 Participants
Sex/Gender, Customized Multiple Genders	6 Participants n=217 Participants
Sex: Female, Male Female	3 Participants n=217 Participants
Sex: Female, Male Male	214 Participants n=217 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=96 Participants • Only participants at the U.S. sites
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=96 Participants • Only participants at the U.S. sites
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=96 Participants • Only participants at the U.S. sites
Race/Ethnicity, Customized Asian	8 Participants n=217 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=217 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=217 Participants
Race/Ethnicity, Customized White	66 Participants n=217 Participants
Race/Ethnicity, Customized Multiple Races	33 Participants n=217 Participants
Race/Ethnicity, Customized Thai	30 Participants n=217 Participants
Race/Ethnicity, Customized Xhosa	5 Participants n=217 Participants
Race/Ethnicity, Customized Zulu	14 Participants n=217 Participants
Race/Ethnicity, Customized Other African Tribe	38 Participants n=217 Participants
Race/Ethnicity, Customized Other	6 Participants n=217 Participants
Region of Enrollment United States	96 Participants n=217 Participants
Region of Enrollment Malawi	31 Participants n=217 Participants
Region of Enrollment South Africa	30 Participants n=217 Participants
Region of Enrollment Thailand	30 Participants n=217 Participants
Region of Enrollment Peru	30 Participants n=217 Participants

PRIMARY outcome

Timeframe: 14 weeks (three 4-week product use periods with 1-week washout periods between them)

Outcome measures

Outcome measures
Measure	Rectal Insert n=201 Participants Participants used rectal inserts in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Suppository n=201 Participants Participants used rectal suppositories in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Douche n=201 Participants Participants used rectal douches in a 4-week period and were instructed to use it prior to any RAI encounter during that period
Acceptability of Future Product Use Yes	143 Participants	132 Participants	143 Participants
Acceptability of Future Product Use No	56 Participants	68 Participants	54 Participants
Acceptability of Future Product Use Missing	2 Participants	1 Participants	4 Participants

PRIMARY outcome

Timeframe: 14 weeks (three 4-week product use periods with 1-week washout periods between them)

Percentage of participants who used each study product as instructed

Outcome measures

Outcome measures
Measure	Rectal Insert n=201 Participants Participants used rectal inserts in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Suppository n=201 Participants Participants used rectal suppositories in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Douche n=201 Participants Participants used rectal douches in a 4-week period and were instructed to use it prior to any RAI encounter during that period
Adherence to Placebo Products Yes	150 Participants	148 Participants	165 Participants
Adherence to Placebo Products No	49 Participants	51 Participants	35 Participants
Adherence to Placebo Products Missing	2 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 14 weeks (three 4-week product use periods with 1-week washout periods between them)

Number of all Grade 2 or higher related adverse events (AE) reported in the study as defined by the DAIDS AE Grading Table

Outcome measures

Outcome measures
Measure	Rectal Insert n=210 Participants Participants used rectal inserts in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Suppository n=209 Participants Participants used rectal suppositories in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Douche n=210 Participants Participants used rectal douches in a 4-week period and were instructed to use it prior to any RAI encounter during that period
Number of Grade 2+ Related Adverse Events	2 Adverse events	0 Adverse events	0 Adverse events

Adverse Events

Rectal Insert

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Rectal Suppository

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Rectal Douche

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Jose A. Bauermeister, PhD

University of Pennsylvania

Phone: 215-898-9993

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Other adverse events
Measure	Rectal Insert n=210 participants at risk Participants used rectal inserts in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Suppository n=209 participants at risk Participants used rectal suppository in a 4-week period and were instructed to use it prior to any RAI encounter during that period	Rectal Douche n=210 participants at risk Participants used rectal douches in a 4-week period and were instructed to use it prior to any RAI encounter during that period
Blood and lymphatic system disorders Lymphadenopathy	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Eye disorders Blepharitis	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Abdominal distension	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Abdominal pain	1.4% 3/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Abdominal pain lower	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Anal erythema	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Anal fissure	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Anal pruritus	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Anal skin tags	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Anorectal discomfort	2.4% 5/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.96% 2/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Anorectal ulcer	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Aphthous ulcer	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Constipation	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Defecation urgency	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Diarrhea	1.9% 4/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	1.4% 3/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	2.4% 5/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Dyschezia	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Flatulence	1.9% 4/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Food poisoning	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Haematemesis	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Haemorrhoids	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Nausea	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Proctalgia	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	1.4% 3/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Rectal tenesmus	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Tooth impacted	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Gastrointestinal disorders Toothache	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
General disorders Hangover	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
General disorders Influenza like illness	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
General disorders Malaise	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
General disorders Pyrexia	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Anal abscess	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Anal chlamydia infection	1.9% 4/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	2.4% 5/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	3.3% 7/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Gastroenteritis	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Genital herpes simplex	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Influenza	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Molluscum contagiosum	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Nasopharyngitis	1.9% 4/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	1.9% 4/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Oropharyngeal gonococcal infection	0.95% 2/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	2.4% 5/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.
Infections and infestations Perineal abscess	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.00% 0/209 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.	0.48% 1/210 • Adverse events were collected beginning at the time of enrollment (i.e., once a participant is randomized) through to the termination visit for an average of 15 weeks.