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| ID | Type | Description | Link |
|---|---|---|---|
| SFPRF14-1 | Other Grant/Funding Number | Society of Family Planning |
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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.
Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Experimental | 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. |
|
| Placebo | Placebo Comparator | Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 7 day course of tamoxifen during an episode of irregular vaginal bleeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Days | 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. | 180 days |
| Bleeding/Spotting Days | Bleeding/spotting days | 30 days |
| Consecutive Bleeding-free Days After Study Drug | Consecutive bleeding-free days after study drug | up to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied) | Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns. | 180 days |
| Number of Participants Experiencing Ovulation After First Use of Study Drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
Study under review for publication
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bleeding Days | 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. | Posted | Mean | Standard Deviation | days | 180 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katharine Simmons | Oregon Health & Science University | 404-718-6619 | simmonka@ohsu.edu |
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| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | 7 day course of placebo during an episode of irregular vaginal bleeding |
|
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. |
| 30 days |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Days of bleeding/spotting in 30 days prior to enrollment | Mean | Standard Deviation | days |
|
|
|
| Primary | Bleeding/Spotting Days | Bleeding/spotting days | 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. | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| Primary | Consecutive Bleeding-free Days After Study Drug | Consecutive bleeding-free days after study drug | 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. | Posted | Mean | Standard Deviation | days | up to 180 days |
|
|
|
| Secondary | Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied) | Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns. | 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. | Posted | Mean | Standard Deviation | units on a scale | 180 days |
|
|
|
| Secondary | Number of Participants Experiencing Ovulation After First Use of Study Drug | 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. | Number of subjects analyzed are those that provided urine samples. No subject who provided urine samples was excluded from this analysis. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 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 | 0 | 28 | 0 | 28 |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |