Trial Outcomes & Findings for Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women (NCT NCT04283656)
NCT ID: NCT04283656
Last Updated: 2025-03-26
Results Overview
Doravirine AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Results posted on
2025-03-26
Participant Flow
Participants were recruited through social media outreach and by interaction with advocacy groups. They were enrolled in the study between January 4, 2022 and September 21, 2022 at the Clinical Research Unit at Thomas Jefferson University.
8 enrolled participants were randomized 1:1 to either Sequence E of F.
Participant milestones
| Measure |
Sequence E
4 of 8 enrolled participants were assigned to receive Sequence E, which consisted of Treatment A, B, and C administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
Sequence F
4 of 8 enrolled participants were assigned to receive Sequence F, which consisted of Treatment C, B, and A administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sequence E
4 of 8 enrolled participants were assigned to receive Sequence E, which consisted of Treatment A, B, and C administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
Sequence F
4 of 8 enrolled participants were assigned to receive Sequence F, which consisted of Treatment C, B, and A administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
Baseline characteristics by cohort
| Measure |
Sequence E
n=4 Participants
4 of 8 enrolled participants were assigned to receive Sequence E, which consisted of Treatment A, B, and C administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
Sequence F
n=4 Participants
4 of 8 enrolled participants were assigned to receive Sequence F, which consisted of Treatment C, B, and A administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.5 years
n=5 Participants
|
27 years
n=7 Participants
|
25.5 years
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Transgender female (male-to-female)
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Transgender male (female-to-male)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Doravirine AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
|
17798.14 hr*ng/mL
Geometric Coefficient of Variation 21.7
|
18413.21 hr*ng/mL
Geometric Coefficient of Variation 41.75
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Doravirine maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Doravirine Maximum Concentration (Cmax)
|
745.46 ng/mL
Geometric Coefficient of Variation 21.43
|
799.67 ng/mL
Geometric Coefficient of Variation 26.01
|
PRIMARY outcome
Timeframe: 24 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Doravirine observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Doravirine Trough Concentration (C24)
|
283.74 ng/mL
Geometric Coefficient of Variation 25.42
|
292.89 ng/mL
Geometric Coefficient of Variation 49.3
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Tenofovir AUC derived from plasma sampling with geometric mean ratio compared between treatment arms
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Tenofovir Disoproxil Fumarate Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
|
2370.6 hr*ng/mL
Geometric Coefficient of Variation 23.42
|
2031.84 hr*ng/mL
Geometric Coefficient of Variation 35.25
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Tenofovir maximum observed concentration during the dosing interval
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Tenofovir Disoproxil Fumarate Maximum Concentration (Cmax)
|
178.84 ng/mL
Geometric Coefficient of Variation 58.4
|
129.95 ng/mL
Geometric Coefficient of Variation 99.92
|
PRIMARY outcome
Timeframe: 24 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Tenofovir observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Tenofovir Disoproxil Fumarate Trough Concentration (C24)
|
29.59 ng/mL
Geometric Coefficient of Variation 24.23
|
26 ng/mL
Geometric Coefficient of Variation 35.77
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Estradiol area under the plasma concentration versus time curve from 0 hours to infinity (AUC) derived from plasma sampling
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Estradiol Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞)
|
9370.25 hr*pg/mL
Geometric Coefficient of Variation 14.36
|
9677.31 hr*pg/mL
Geometric Coefficient of Variation 43.29
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Estradiol maximum observed concentration during the dosing interval with geometric mean ratio compared between treatment arms
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Estradiol Maximum Concentration (Cmax)
|
118.08 pg/mL
Geometric Coefficient of Variation 20.5
|
105.14 pg/mL
Geometric Coefficient of Variation 21.26
|
PRIMARY outcome
Timeframe: 12 hours post-dose for all participantsPopulation: 6 participants completed the study and were included in the pharmacokinetic analysis.
Estradiol observed trough concentration during the dosing interval with geometric mean ratio compared between treatment arms
Outcome measures
| Measure |
Treatment C
n=6 Participants
Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily
|
Treatment A
n=6 Participants
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily
|
|---|---|---|
|
Estradiol Trough Concentration (C12)
|
100.26 pg/mL
Geometric Coefficient of Variation 26.56
|
92.01 pg/mL
Geometric Coefficient of Variation 36.94
|
Adverse Events
Sequence E
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sequence F
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sequence E
n=4 participants at risk
All subjects received all treatments, and as such the comparisons are between sequences.
Adverse events were not separated out by treatment, but only by Sequence
4 of 8 enrolled participants were assigned to receive Sequence E, which consisted of Treatment A, B, and C administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
Sequence F
n=4 participants at risk
All subjects received all treatments, and as such the comparisons are between sequences.
Adverse events were not separated out by treatment, but only by Sequence
4 of 8 enrolled participants were assigned to receive Sequence F, which consisted of Treatment C, B, and A administered during period I, II, and III, respectively.
Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Treatment B: Single-dose estradiol and spironolactone co-administered with placebo Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Doravirine/Lamivudine/Tenofovir: 100mg/300mg/300mg orally for one dose, daily Spironolactone 100mg: 200mg orally for two doses, twice-daily Estradiol 2mg: 4mg orally for two doses, twice-daily Placebo: Placebo for one dose, daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/vomiting
|
50.0%
2/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
General disorders
Fatigue
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
General disorders
Application site erythema
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
General disorders
Catheter site redness
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Infections and infestations
Folliculitis
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Investigations
Blood glucose increased
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Nervous system disorders
Brain fog
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Nervous system disorders
Migraine
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Distractibility
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Dysphoria
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Irritability
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Gender dysphoria
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Libido increased
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Mood swings
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
|
Psychiatric disorders
Seborrhoea
|
25.0%
1/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
0.00%
0/4 • 9 weeks, up to 30 days after last dose of drug administered
Adverse events were collected throughout the duration of the study, up to 30 days after last dose of drug administered. All subjects received all treatments, and as such the comparisons are between sequences. Adverse events were not separated out by treatment, but only by Sequence. Adverse Events were monitored without regard to the specific intervention or period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place