Participant flow

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms · Source last updated 2019-02-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.

   id

   FG000

   title

   Arm I Low Dose DHEA

2. description

   Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.

   id

   FG001

   title

   Arm II High Dose DHEA

3. description

   Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.

   id

   FG002

   title

   Arm III Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         13

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         14

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      type

      Unkown

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Alternative Treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         147

      2. group Id

         FG001

         num Subjects

         149

      3. group Id

         FG002

         num Subjects

         147

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         123

      2. group Id

         FG001

         num Subjects

         114

      3. group Id

         FG002

         num Subjects

         118

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         35

      3. group Id

         FG002

         num Subjects

         29

      type

      NOT COMPLETED

   title

   Raondomized Treatment

2. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. comment

         Patients completing Arm III Placebo were offered the option of continuing High Dose DHEA

         group Id

         FG002

         num Subjects

         94

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         94

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Optional Continuation Phase

pre Assignment Details

A total of 464 patients were accrued to this trial. Nineteen patients withdrew consent prior to randomization and were not included in the analysis of this study. Two additional patients were unable to classify the primary symptom and were not randomized to the trial and were not included in the analysis.

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Preserved source evidence · Not medical advice