Trial Outcomes & Findings for Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir (NCT NCT03670355)

NCT ID: NCT03670355

Last Updated: 2025-11-13

Results Overview

TFV concentrations as assessed by drug detection testing in plasma samples collected at multiple timepoints during the study.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 49 participants
• Primary outcome timeframe: Measured through Day 92
• Results posted on: 2025-11-13

Participant Flow

49 participants were enrolled and randomized in 3 U.S. medical clinic sites from January 2, 2019 until June 25, 2019.

49 participants were enrolled in the study and randomized to study product simultaneously.

Participant milestones

Measure	Tenofovir (TFV) Intravaginal Ring (IVR) The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV	Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo
Overall Study STARTED	33	16
Overall Study COMPLETED	32	14
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Tenofovir (TFV) Intravaginal Ring (IVR) The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV	Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo
Overall Study Adverse Event	1	0
Overall Study Unable to comply with study procedures	0	1
Overall Study Participant refused	0	1

Baseline Characteristics

Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir

Baseline characteristics by cohort

Measure	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV	Placebo IVR n=16 Participants The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Total n=49 Participants Total of all reporting groups
Age, Continuous	29.0 years n=10 Participants	27.5 years n=10 Participants	29.0 years n=20 Participants
Age, Customized Missing	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Customized 18-19 years	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Age, Customized 20-24 years	7 Participants n=10 Participants	5 Participants n=10 Participants	12 Participants n=20 Participants
Age, Customized 25-29 years	8 Participants n=10 Participants	5 Participants n=10 Participants	13 Participants n=20 Participants
Age, Customized 30-34 years	7 Participants n=10 Participants	2 Participants n=10 Participants	9 Participants n=20 Participants
Age, Customized 35-39 years	7 Participants n=10 Participants	2 Participants n=10 Participants	9 Participants n=20 Participants
Age, Customized 40-45 years	2 Participants n=10 Participants	2 Participants n=10 Participants	4 Participants n=20 Participants
Sex/Gender, Customized Female	32 Participants n=10 Participants	14 Participants n=10 Participants	46 Participants n=20 Participants
Sex/Gender, Customized Gender Nonconforming/Gender Variant	1 Participants n=10 Participants	2 Participants n=10 Participants	3 Participants n=20 Participants
Sex: Female, Male Female	33 Participants n=10 Participants	16 Participants n=10 Participants	49 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=10 Participants	15 Participants n=10 Participants	46 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race/Ethnicity, Customized Asian	4 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=10 Participants	3 Participants n=10 Participants	11 Participants n=20 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race/Ethnicity, Customized White	18 Participants n=10 Participants	8 Participants n=10 Participants	26 Participants n=20 Participants
Race/Ethnicity, Customized Other	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Race/Ethnicity, Customized Mixed	2 Participants n=10 Participants	4 Participants n=10 Participants	6 Participants n=20 Participants
Race/Ethnicity, Customized Missing	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Biological Gender of sex partners Both Male and Female	4 Participants n=10 Participants	3 Participants n=10 Participants	7 Participants n=20 Participants
Biological Gender of sex partners Exclusively Female Partners	3 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants
Biological Gender of sex partners Exclusively Male Partners	19 Participants n=10 Participants	9 Participants n=10 Participants	28 Participants n=20 Participants
Biological Gender of sex partners No Sex Partners	7 Participants n=10 Participants	2 Participants n=10 Participants	9 Participants n=20 Participants

PRIMARY outcome

Timeframe: Measured through Day 92

Population: This endpoint includes results from samples collected only from participants randomized to the TFV IVR arm. The samples from participants randomized to placebo will not have any TFV concentrations (outcome measure) in their plasma.

TFV concentrations as assessed by drug detection testing in plasma samples collected at multiple timepoints during the study.

Outcome measures

Measure	Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Measurement of TFV Levels in Plasma Day 1 postdosing	—	636.8 pg/mL Geometric Coefficient of Variation 131.2
Measurement of TFV Levels in Plasma Day 7 postdosing	—	1915.9 pg/mL Geometric Coefficient of Variation 102.3
Measurement of TFV Levels in Plasma Day 14 postdosing	—	3581.5 pg/mL Geometric Coefficient of Variation 114.7
Measurement of TFV Levels in Plasma Day 28 postdosing	—	5040.7 pg/mL Geometric Coefficient of Variation 235.0
Measurement of TFV Levels in Plasma Day 56 postdosing	—	7862.3 pg/mL Geometric Coefficient of Variation 139.6
Measurement of TFV Levels in Plasma Day 91 postdosing	—	1814.6 pg/mL Geometric Coefficient of Variation 612.2
Measurement of TFV Levels in Plasma Day 91, 4 hours post-removal	—	1081.2 pg/mL Geometric Coefficient of Variation 426.9
Measurement of TFV Levels in Plasma Day 92, 24 hours post-removal	—	236.2 pg/mL Geometric Coefficient of Variation 127.4

PRIMARY outcome

Timeframe: Measured through Day 92

Population: This endpoint includes results from samples collected only from participants randomized to the TFV IVR arm. The samples from participants randomized to placebo will not have any TFV concentrations (outcome measure) in their CVF.

TFV concentrations as assessed by drug detection testing in CVF samples collected at multiple timepoints during the study.

Outcome measures

Measure	Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 92, 24 hours post-removal	—	7.2 ng/mg Geometric Coefficient of Variation 85571.4
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 0, Hour 1 postdosing	—	3 ng/mg Geometric Coefficient of Variation 95.3
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 0, Hour 4 postdosing	—	6.2 ng/mg Geometric Coefficient of Variation 92.6
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 1 postdosing	—	437.8 ng/mg Geometric Coefficient of Variation 75.1
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 7 postdosing	—	1468.2 ng/mg Geometric Coefficient of Variation 129.9
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 14 postdosing	—	2006.4 ng/mg Geometric Coefficient of Variation 57.2
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 28 postdosing	—	2011.8 ng/mg Geometric Coefficient of Variation 288.6
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 56 postdosing	—	2817.1 ng/mg Geometric Coefficient of Variation 70.8
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 91 postdosing	—	270.5 ng/mg Geometric Coefficient of Variation 24859.2
Measurement of TFV Levels in Cervicovaginal Fluid (CVF) Day 91, 4 hours post-removal	—	41.3 ng/mg Geometric Coefficient of Variation 406784.3

PRIMARY outcome

Timeframe: Measured through Day 92

Population: This endpoint includes results from samples collected only from participants randomized to the TFV IVR arm. The samples from participants randomized to placebo will not have any TFV concentrations (outcome measure) in their rectal fluid.

TFV concentrations as assessed by drug detection testing in rectal fluid samples collected at multiple timepoints during the study.

Outcome measures

Measure	Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Measurement of TFV Levels in Rectal Fluid Day 1 postdosing	—	293.6 pg/mg Geometric Coefficient of Variation 1111.0
Measurement of TFV Levels in Rectal Fluid Day 14 postdosing	—	701.8 pg/mg Geometric Coefficient of Variation 583.2
Measurement of TFV Levels in Rectal Fluid Day 28 postdosing	—	898.3 pg/mg Geometric Coefficient of Variation 1355.9
Measurement of TFV Levels in Rectal Fluid Day 56 postdosing	—	1377.3 pg/mg Geometric Coefficient of Variation 475.9
Measurement of TFV Levels in Rectal Fluid Day 91 postdosing	—	460.3 pg/mg Geometric Coefficient of Variation 1093.3
Measurement of TFV Levels in Rectal Fluid Day 91, 4 hours post-removal	—	416.7 pg/mg Geometric Coefficient of Variation 4315.6

PRIMARY outcome

Timeframe: Measured through Day 92

Population: This endpoint includes results from samples collected only from participants randomized to the TFV IVR arm. The samples from participants randomized to placebo will not have any TFV concentrations (outcome measure) in their cervical tissue. In addition, one participant on the TFV IVR arm declined collection of cervical tissue samples and is not included in the number analyzed.

TFV concentrations as assessed by drug detection testing in cervical tissue samples collected at multiple timepoints during the study.

Outcome measures

Measure	Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=32 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Measurement of TFV Levels in Cervical Tissue Day 14 postdosing	—	45.9 ng/mg Geometric Coefficient of Variation 11800.2
Measurement of TFV Levels in Cervical Tissue Day 28 postdosing	—	39.1 ng/mg Geometric Coefficient of Variation 322.8
Measurement of TFV Levels in Cervical Tissue Day 56 postdosing	—	37.1 ng/mg Geometric Coefficient of Variation 177.1
Measurement of TFV Levels in Cervical Tissue Day 91 postdosing	—	6.5 ng/mg Geometric Coefficient of Variation 254895.9

PRIMARY outcome

Timeframe: Measured through Day 92

Population: This endpoint includes results from samples collected only from participants randomized to the TFV IVR arm. The samples from participants randomized to placebo will not have any TFV-DP concentrations (outcome measure) in their cervical tissue. In addition, one participant on the TFV IVR arm refused cervical tissue sample collection.

TFV-DP concentrations as assessed by drug detection testing in cervical tissue samples collected at multiple timepoints during the study.

Outcome measures

Measure	Placebo IVR The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=32 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Measurement of Tenofovir Diphosphate (TFV-DP) Levels in Cervical Tissue Day 14 postdosing	—	2679.5 fmol/mg Geometric Coefficient of Variation 82.6
Measurement of Tenofovir Diphosphate (TFV-DP) Levels in Cervical Tissue Day 28 postdosing	—	3217.8 fmol/mg Geometric Coefficient of Variation 85.6
Measurement of Tenofovir Diphosphate (TFV-DP) Levels in Cervical Tissue Day 56 postdosing	—	1892.6 fmol/mg Geometric Coefficient of Variation 178.3
Measurement of Tenofovir Diphosphate (TFV-DP) Levels in Cervical Tissue Day 91 postdosing	—	456.2 fmol/mg Geometric Coefficient of Variation 16735.9

PRIMARY outcome

Timeframe: Measured through Day 92

Population: Includes all participants enrolled and randomized to this study.

As defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, and/or Addendum 1 (Female Genital [Dated November 2007] Grading Table for Use in Microbicide Studies)

Outcome measures

Measure	Placebo IVR n=16 Participants The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Proportion of Participants With Grade 2 or Higher Genitourinary Adverse Event	4 Participants	4 Participants

PRIMARY outcome

Timeframe: Measured through Day 92

As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

Outcome measures

Measure	Placebo IVR n=16 Participants The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Proportion of Participants With Grade 3 or Higher Adverse Event	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured through Day 92

Population: The analysis includes all enrolled and randomized participants.

Participants were classified as fully adherent if they kept the study ring inserted at all times during the 91 days of study product use, without any product hold (according to the Product Hold Log eCRF) or ever having the ring out (by self-report in the Ring Adherence eCRF). Ring outages could be ring removals or expulsions (voluntary or involuntary).

Outcome measures

Measure	Placebo IVR n=16 Participants The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Number of Participants Fully Adherent to the Study IVR Adherent	13 Participants	28 Participants
Number of Participants Fully Adherent to the Study IVR Non-Adherent	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Measured through Day 92

Population: This analysis includes only participants where were not fully adherent.

This includes only participants considered non-adherent. Participants were classified as fully adherent if they kept the study ring inserted at all times during the 91 days of study product use, without any product hold (according to the Product Hold Log eCRF) or ever having the ring out (by self-report in the Ring Adherence eCRF).

Outcome measures

Measure	Placebo IVR n=3 Participants The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=5 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Duration Without IVR in Vagina for Participants Not Fully Adherent	10.0 hours Standard Deviation 14.1	15.2 hours Standard Deviation 23.1

SECONDARY outcome

Timeframe: Measured on the end of study, Day 92, visit.

Population: This outcome includes all participants who completed the final product use end visit (PUEV) behavioral questionnaire with non-missing response to question J2 "Overall, how much do you like the ring?"

This outcome uses question J2 "Overall, how much do you like the ring?" from the final product use end visit (PUEV) behavioral questionnaire. This question and one timepoint were prespecified in the Statistical Analysis Plan (SAP) section 9.2 to represent the participants' overall acceptability of the study product. The question response is on a 10-point Likert scale from 1 to 10 with 1 being extremely dislike to 10 being extremely like. A Likert scale score of 5 is neutral.

Outcome measures

Measure	Placebo IVR n=16 Participants The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Placebo IVR: Contains placebo	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 Participants The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days. Tenofovir (TFV) IVR: Contains 1.4 g TFV
Degree to Which Participants Like or Dislike Using the IVR	8 Score on a scale Interval 7.0 to 10.0	8 Score on a scale Interval 7.0 to 9.0

Adverse Events

Tenofovir (TFV) Intravaginal Ring (IVR)

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo IVR

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tenofovir (TFV) Intravaginal Ring (IVR) n=33 participants at risk The TFV IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days.Tenofovir (TFV) IVR: Contains 1.4 g TFV	Placebo IVR n=16 participants at risk The placebo IVR will be inserted during the enrollment visit (Day 0) and used continuously for approximately 91 days.Placebo IVR: Contains placebo
Gastrointestinal disorders Abdominal distension	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Gastrointestinal disorders Abdominal pain lower	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Gastrointestinal disorders Diarrhoea	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Gastrointestinal disorders Haemorrhoids	6.1% 2/33 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Gastrointestinal disorders Nausea	6.1% 2/33 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
General disorders Fatigue	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
General disorders Suprapubic pain	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Bacterial vaginosis	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Escherichia urinary tract infection	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Pelvic inflammatory disease	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Tonsillitis	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Tooth infection	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Upper respiratory tract infection	18.2% 6/33 • Number of events 9 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	18.8% 3/16 • Number of events 5 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Viral infection	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Vulvovaginal candidiasis	12.1% 4/33 • Number of events 5 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	12.5% 2/16 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Vulvovaginitis	6.1% 2/33 • Number of events 3 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Infections and infestations Vulvovaginitis trichomonal	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Injury, poisoning and procedural complications Eye injury	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Injury, poisoning and procedural complications Post procedural haemorrhage	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Injury, poisoning and procedural complications Vaginal laceration	3.0% 1/33 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Investigations Blood creatinine increased	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Investigations Urine output decreased	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Investigations Weight increased	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Musculoskeletal and connective tissue disorders Back pain	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Nervous system disorders Dizziness	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Nervous system disorders Headache	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Nervous system disorders Sinus headache	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Renal and urinary disorders Dysuria	6.1% 2/33 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Renal and urinary disorders Micturition urgency	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Renal and urinary disorders Pollakiuria	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Renal and urinary disorders Urinary retention	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	12.5% 2/16 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Dyspareunia	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Menorrhagia	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	18.8% 3/16 • Number of events 3 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Metrorrhagia	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	12.5% 2/16 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Pelvic discomfort	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Uterine pain	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Uterine spasm	6.1% 2/33 • Number of events 2 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Vaginal discharge	42.4% 14/33 • Number of events 17 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	50.0% 8/16 • Number of events 9 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Vaginal odour	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	18.8% 3/16 • Number of events 3 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Vulval ulceration	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Vulvovaginal discomfort	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Vulvovaginal erythema	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Reproductive system and breast disorders Vulvovaginal pruritus	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Skin and subcutaneous tissue disorders Dermatitis contact	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Skin and subcutaneous tissue disorders Intertrigo	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Skin and subcutaneous tissue disorders Papule	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Skin and subcutaneous tissue disorders Rash	3.0% 1/33 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	0.00% 0/16 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/33 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.	6.2% 1/16 • Number of events 1 • Participants are followed for adverse events during study follow-up which was scheduled up to 3 months (92 days) per participant As described in section 8.3.1 of the protocol document, study participants will be provided instructions for contacting the study site to report any untoward medical occurrences they may experience. Where feasible and medically appropriate, participants will be encouraged to seek evaluation where a study clinician is based. All participants reporting an untoward medical occurrence will be followed clinically until the occurrence resolves (returns to baseline) or stabilizes.

Additional Information

Dr. Albert Liu

San Francisco Department of Public Health

Phone: 4154377408

Email: albert.liu@sfdph.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place