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Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial

Primary Purpose

Vaginal Bleeding

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tamoxifen Citrate 10Mg Tab
Estradiol
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaginal Bleeding

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • etonogestrel implant users
  • at time of and/or within 21 days of initial use of etonogestrel implant placement
  • must agree not to take additional hormonal therapy during the study trial period

Exclusion Criteria:

  • within 6 months following vaginal or cesarean delivery
  • within 6 weeks following abortion
  • currently breastfeeding
  • positive pregnancy test
  • contraindications to tamoxifen or estrogen
  • history of thromboembolism
  • undiagnosed abnormal uterine bleeding
  • active cervicitis
  • bleeding disorder
  • use of anticoagulation medications
  • an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria

Sites / Locations

  • Shanthi Ramesh
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Tamoxifen

Estradiol

placebo

Arm Description

tamoxifen 10mg daily for 7 days

estradiol 1mg daily for 7 days

placebo daily for 7 days

Outcomes

Primary Outcome Measures

Duration of bleeding free days
Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding

Secondary Outcome Measures

Total number of bleeding free days
Total number of no spotting or bleeding days
Days to first re-treatment
Number of days between first and second use of medication
Total number of re-treatments
Total number of times participant used treatment medication
Satisfaction with bleeding
Average satisfaction with bleeding will be assess using daily text surveys. Participants will rate degree of satisfaction with bleeding with the use of symbols (emojis): 1) completely unsatisfied, 2) somewhat unsatisfied, 3) neutral, 4) somewhat satisfied, 5) completely satisfied.
Affects on daily life activities
The average affect of bleeding on daily life activities will be assess using daily text surveys. Participants will rate the degree of affects of bleeding on daily life with the use of a visual analogue scale from 0 (no affects) to 100 (highest possible affects)

Full Information

First Posted
June 14, 2021
Last Updated
May 31, 2022
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04933240
Brief Title
Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial
Official Title
Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Anticipated funding was not received
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this research study is to evaluate the ability of medicines called tamoxifen or estradiol to prevent annoying vaginal bleeding for arm implant users.
Detailed Description
This pilot study compares the use of tamoxifen to estradiol to placebo for seven days once a month up to 5 months in contraceptive implant users starting from the time of implant initiation. Participants will record bleeding and satisfaction response in a daily text diary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen
Arm Type
Active Comparator
Arm Description
tamoxifen 10mg daily for 7 days
Arm Title
Estradiol
Arm Type
Active Comparator
Arm Description
estradiol 1mg daily for 7 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Tamoxifen Citrate 10Mg Tab
Other Intervention Name(s)
NOLVADEX
Intervention Description
nonsteroidal antiestrogen for oral administration in 10 mg tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.
Intervention Type
Drug
Intervention Name(s)
Estradiol
Other Intervention Name(s)
ESTRACE
Intervention Description
estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive drug
Intervention Description
A sugar tablet that does not contain any active medicine
Primary Outcome Measure Information:
Title
Duration of bleeding free days
Description
Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Total number of bleeding free days
Description
Total number of no spotting or bleeding days
Time Frame
Up to 24 weeks
Title
Days to first re-treatment
Description
Number of days between first and second use of medication
Time Frame
Up to 24 weeks
Title
Total number of re-treatments
Description
Total number of times participant used treatment medication
Time Frame
Up to 24 weeks
Title
Satisfaction with bleeding
Description
Average satisfaction with bleeding will be assess using daily text surveys. Participants will rate degree of satisfaction with bleeding with the use of symbols (emojis): 1) completely unsatisfied, 2) somewhat unsatisfied, 3) neutral, 4) somewhat satisfied, 5) completely satisfied.
Time Frame
Up to 24 weeks
Title
Affects on daily life activities
Description
The average affect of bleeding on daily life activities will be assess using daily text surveys. Participants will rate the degree of affects of bleeding on daily life with the use of a visual analogue scale from 0 (no affects) to 100 (highest possible affects)
Time Frame
Up to 24 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: etonogestrel implant users at time of and/or within 21 days of initial use of etonogestrel implant placement must agree not to take additional hormonal therapy during the study trial period Exclusion Criteria: within 6 months following vaginal or cesarean delivery within 6 weeks following abortion currently breastfeeding positive pregnancy test contraindications to tamoxifen or estrogen history of thromboembolism undiagnosed abnormal uterine bleeding active cervicitis bleeding disorder use of anticoagulation medications an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Casey, MD, MPH
Organizational Affiliation
VCU Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanthi Ramesh
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23221
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31176688
Citation
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Results Reference
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PubMed Identifier
32649493
Citation
Edelman AB, Kaneshiro B, Simmons KB, Hauschildt JL, Bond K, Boniface ER, Jensen JT. Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):323-332. doi: 10.1097/AOG.0000000000003896.
Results Reference
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PubMed Identifier
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Citation
Abdel-Aleem H, d'Arcangues C, Vogelsong KM, Gaffield ML, Gulmezoglu AM. Treatment of vaginal bleeding irregularities induced by progestin only contraceptives. Cochrane Database Syst Rev. 2013 Oct 21;(10):CD003449. doi: 10.1002/14651858.CD003449.pub5.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Buzdar AU, Hortobagyi GN, Frye D, Ho D, Booser DJ, Valero V, Holmes FA, Birmingham BK, Bui K, Yeh C, et al. Bioequivalence of 20-mg once-daily tamoxifen relative to 10-mg twice-daily tamoxifen regimens for breast cancer. J Clin Oncol. 1994 Jan;12(1):50-4. doi: 10.1200/JCO.1994.12.1.50. Erratum In: J Clin Oncol 1994 Jun;12(6):1337.
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Citation
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Citation
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Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial

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