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Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

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ClinicalTrials.gov Identifier: NCT02070692
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : June 14, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Katharine Simmons, MD, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Menstruation Disturbances
Interventions Drug: Tamoxifen
Drug: Placebo
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

Period Title: Overall Study
Started 28 28
Completed 18 16
Not Completed 10 12
Arm/Group Title Tamoxifen Placebo Total
Hide Arm/Group Description

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
25.4
(18 to 36)
23.9
(15 to 38)
24.6
(15 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
28
 100.0%
28
 100.0%
56
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
American Indian or Alaska Native
1
   3.6%
1
   3.6%
2
   3.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   3.6%
1
   1.8%
Black or African American
1
   3.6%
3
  10.7%
4
   7.1%
White
25
  89.3%
20
  71.4%
45
  80.4%
More than one race
1
   3.6%
1
   3.6%
2
   3.6%
Unknown or Not Reported
0
   0.0%
2
   7.1%
2
   3.6%
Days of bleeding/spotting in 30 days prior to enrollment  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 28 participants 28 participants 56 participants
17.3  (8.5) 22.2  (6.6) 19.75  (7.9)
1.Primary Outcome
Title Bleeding Days
Hide Description The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: days
65.6  (37.5) 46.9  (28.1)
2.Primary Outcome
Title Bleeding/Spotting Days
Hide Description Bleeding/spotting days
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients analyzed is number of patients who completed 30 days of follow up. Two subjects in the tamoxifen arm and three in the placebo arm were lost to follow up prior to 30 days.
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

Overall Number of Participants Analyzed 26 25
Mean (Standard Deviation)
Unit of Measure: days
10.5  (9.0) 15.5  (8.5)
3.Primary Outcome
Title Consecutive Bleeding-free Days After Study Drug
Hide Description Consecutive bleeding-free days after study drug
Time Frame up to 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects analyzed is the number of subjects who started taking the study drug. One subject in the tamoxifen arm and there in the placebo arm did not initiate study drug.
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: days
28.8  (24.5) 13.6  (19.2)
4.Secondary Outcome
Title Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)
Hide Description Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects analyzed is the number of subjects who completed a final study visit (either completion of full study or early termination visit) to provide a final estimation of satisfaction.
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
61.4  (24.7) 53.6  (33.3)
5.Secondary Outcome
Title Number of Participants Experiencing Ovulation After First Use of Study Drug
Hide Description A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects analyzed are those that provided urine samples. No subject who provided urine samples was excluded from this analysis.
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

Overall Number of Participants Analyzed 19 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description

Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.

Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding

All-Cause Mortality
Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Katharine Simmons
Organization: Oregon Health & Science University
Phone: 404-718-6619
Responsible Party: Katharine Simmons, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02070692     History of Changes
Other Study ID Numbers: SFPRF14-1
SFPRF14-1 ( Other Grant/Funding Number: Society of Family Planning )
First Submitted: February 21, 2014
First Posted: February 25, 2014
Results First Submitted: April 3, 2017
Results First Posted: June 14, 2017
Last Update Posted: July 2, 2017