Trial Outcomes & Findings for Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users (NCT NCT02070692)

NCT ID: NCT02070692

Last Updated: 2017-07-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

56 participants

Primary outcome timeframe

180 days

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Tamoxifen 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 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 Study STARTED	28	28
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamoxifen n=28 Participants 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 n=28 Participants 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 n=56 Participants Total of all reporting groups
Age, Continuous	25.4 years n=5 Participants	23.9 years n=7 Participants	24.6 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Days of bleeding/spotting in 30 days prior to enrollment	17.3 days STANDARD_DEVIATION 8.5 • n=5 Participants	22.2 days STANDARD_DEVIATION 6.6 • n=7 Participants	19.75 days STANDARD_DEVIATION 7.9 • n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	Tamoxifen n=18 Participants 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 n=16 Participants 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
Bleeding Days	65.6 days Standard Deviation 37.5	46.9 days Standard Deviation 28.1

PRIMARY outcome

Timeframe: 30 days

Population: 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.

Bleeding/spotting days

Outcome measures

Outcome measures
Measure	Tamoxifen n=26 Participants 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 n=25 Participants 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
Bleeding/Spotting Days	10.5 days Standard Deviation 9.0	15.5 days Standard Deviation 8.5

PRIMARY outcome

Timeframe: up to 180 days

Population: 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.

Consecutive bleeding-free days after study drug

Outcome measures

Outcome measures
Measure	Tamoxifen n=27 Participants 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 n=25 Participants 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
Consecutive Bleeding-free Days After Study Drug	28.8 days Standard Deviation 24.5	13.6 days Standard Deviation 19.2

SECONDARY outcome

Timeframe: 180 days

Population: 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.

Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.

Outcome measures

Outcome measures
Measure	Tamoxifen n=22 Participants 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 n=21 Participants 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
Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)	61.4 units on a scale Standard Deviation 24.7	53.6 units on a scale Standard Deviation 33.3

SECONDARY outcome

Timeframe: 30 days

Population: Number of subjects analyzed are those that provided urine samples. No subject who provided urine samples was excluded from this analysis.

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.

Outcome measures

Outcome measures
Measure	Tamoxifen n=19 Participants 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 n=22 Participants 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
Number of Participants Experiencing Ovulation After First Use of Study Drug	0 Participants	0 Participants

Adverse Events

Tamoxifen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katharine Simmons

Oregon Health & Science University

Phone: 404-718-6619

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place