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Leiomyoma

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Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Ulipristal acetate

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.

Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Ulipristal acetate (UPA)

Placebo

Anna Chan

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Females suffering with abnormal uterine bleeding associated with leiomyomas were treated in this study.

A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.

Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), from Day 11 to the end of treatment in Treatment Course 1.

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 2.

Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 2.

The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.

Allergan

Safety population included all participants who received study drug analyzed per treatment actually received. 1 patient randomized to UPA 5 mg:Placebo and 2 patients randomized to UPA 10 mg:Placebo actually received placebo in Treatment Course 1; are included in Placebo arm. 1 patient randomized to UPA 5 mg:Placebo actually received Placebo:UPA 5 mg; is included in Placebo:UPA 5 mg arm and 3 patients who received placebo in both courses are not included in safety analyses in Treatment Course 2.

Matching placebo tablets, orally, once daily for 12 weeks in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.

Placebo (Treatment Course 1)

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.

UPA 5 mg (Treatment Course 1)

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in Treatment Course 1. Includes AEs that occurred in Treatment Course 1 and the 2 menses drug-free interval.

UPA 10 mg (Treatment Course 1)

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by placebo matching tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.

UPA 5 mg:Placebo (Treatment Course 2)

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.

UPA 10 mg:Placebo (Treatment Course 2)

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.

UPA 5 mg:UPA 5 mg (Treatment Course 2)

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.

UPA 10 mg:UPA 10 mg (Treatment Course 2)

Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.

Placebo:UPA 5 mg (Treatment Course 2)

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. Includes AEs that occurred in Treatment Course 2 and 12 week follow-up.

Placebo:UPA 10 mg (Treatment Course 2)

UPA 5 mg:Placebo

UPA 10 mg:Placebo

UPA 5 mg:UPA 5 mg

UPA 10 mg:UPA 10 mg

Placebo:UPA 5 mg

Placebo:UPA 10 mg

Total

Age, Continuous

Sex: Female, Male

The Intent-to-Treat (ITT) population included all randomized participants.

Therapeutic Area, Head

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1.

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.

UPA 5 mg

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1.

UPA 10 mg

Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1

ITT population included all randomized participants. Data was summarized per treatment assigned.

Time to Absence of Bleeding on Treatment During Treatment Course 1

ITT population included all randomized participants. Data was summarized as per the treatment assigned.

Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.

Data was summarized as per the treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2

Data was summarized as per treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.

Time to Absence of Bleeding on Treatment During Treatment Course 2

Baseline

Change from Baseline at Week 12

Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12 in Treatment Course 1.

Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1

Treatment Course 1

Off-Treatment Interval 1

Treatment Course 2

Off-Treatment Interval 2

Breast Neoplasms

Ethinyl estradiol, levonorgestrel drug combination

Contraceptives, Oral

Contraceptives, Oral, Combined

20 women will randomized to daily use of 10mg of ulipristal acetate

20 women will be randomized to daily use of a combined oral contraceptive pill

Ulipristal Acetate

Combined Oral Contraceptive Pill

Carolyn Westhoff, MD

Breast cancer accounts for almost a quarter of all cancers in women. In the United States (U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer. There is an urgent need to develop acceptable means of preventing breast cancer both for high risk and average risk women.

The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation (increase in number of cells in the breast) and to measure its effect compared to that found with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use as daily medication up to 12 months for the treatment of abnormally heavy bleeding at menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its use as a daily contraceptive.

The investigators will use breast biopsies to compare breast cell proliferation, comparing biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA and COC). The investigators will also compare the changes in the 2 groups to each other. The comparison of the effect of UPA to that of a conventional COC is because of UPA's potential use as a daily contraceptive.

Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of hormones on the breast are rapid and an anti-progestin such as UPA, which will block the action of progesterone in the breast, would be predicted to quickly lower breast cell proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and are reassuring. COC use has not been found to lower breast cell proliferation and is not associated with any decrease in risk of breast cancer.

The changes in breast cell proliferation will also be compared to changes seen on breast MRI. If the changes are highly correlated future studies will be able to be done without the need for breast biopsies.

This will be a randomized controlled parallel group clinical trial with blinded evaluation to be carried out at 2 academic medical centers: Columbia University Medical Center and Weill Cornell Medical College. The investigators will screen healthy women aged 18-39 who meet inclusion/exclusion criteria and will enroll them for the study.

After the informed consent process and study enrollment, study participation will begin with a baseline cycle. The main goal of the baseline cycle is to identify the occurrence and the timing of ovulation. Starting at about day 6 of the baseline cycle, participants will undergo blood sampling for progesterone (P4) levels at intervals of every 2-3 days. An increase of P4 to greater than 3 ng/mL, confirmed by a second such value, will indicate ovulation and eligibility to continue in the study. The participant's baseline breast MRI and biopsy (see below) will be scheduled to occur in the mid luteal phase, about 7 days after the first increase (\>3 ng/mL) in P4. The investigators will randomly assign which breast has the first biopsy, and women will return for a post-biopsy visit about 7 days later. At the post-biopsy visit, the investigators will assess acceptability of the MRI and biopsy to the participants using visual analog scales (VAS) as well as interview.

At the beginning of the next menstrual period, women will begin the treatment phase of the study. They will receive random assignment to either UPA or COC at the study center and receive their first dose and a 4-week supply of study drug. During cycles 1 and 2 they will return to the study site every 2 weeks for assessment, blood draws and to receive the next cycle of study drug. During the third cycle, they will return to the study site twice weekly for more frequent testing and monitoring. Each cycle will be 28 days, corresponding to usual COC packaging. At day 75-77 of treatment women will undergo the second breast MRI, immediately followed by a biopsy of the contralateral breast to that biopsied at baseline. An end-of-study visit, including checking the incision site and a repeat assessment of acceptability of the MRI and biopsy to the participants, will occur about 7 days later. Participants will also be asked to rate their preference for an MRI versus a biopsy, were it possible to do a study with only one of these procedures.

Participants will have up to 24 study visits, and at each visit, participants will be asked about adverse events and use of any concomitant medications. Participants will have a high sensitivity urine pregnancy test at baseline and immediately preceding each MRI and preceding the first dose of study medication. Any participant with a positive pregnancy test will be immediately withdrawn from the study.

Breast Biopsies Breast biopsies will take place immediately following each breast MRI. Women will receive 24-hour telephone follow-up, and make a visit within one week following each breast biopsy to ensure that the biopsy site is healing without incident.

MRI For each participant, the baseline and follow-up MRI will be done using the same machine. Each MRI study will undergo an immediate wet read to assure adequate quality and to identify any unexpected pathology that would mandate clinical evaluation and withdrawal from the study. A limited report indicating technical adequacy and absence of major clinical abnormalities will be recorded in the patient record.

Breast MRI and breast biopsy visits will take place at the Center for Breast Imaging at Columbia University Medical Center.

Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation

A Prospective, Randomized, Single-blind Study to Compare the Effects of Daily Ulipristal Acetate (UPA) 10mg With a Combined Oral Contraceptive (COC) Pill on Breast Epithelial Cell Proliferation in Reproductive Age Women

The breast biopsies will be analyzed (measured by Ki67) at end of study treatment, as compared with baseline before initiation of treatment.

The breast biopsies will be analyzed (measured by Ki67).

Weill Medical College of Cornell University

Memorial Sloan Kettering Cancer Center

Columbia University

Professor, Department of Obstetrics and Gynecology

Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.

UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.

Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.

Females with abnormal uterine bleeding associated with leiomyomas were treated in this study.

A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in the 12-week Treatment Period.

Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose on treatment. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose on treatment in the 12-week Treatment Period.

Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), starting from Day 11 through the end of the 12-week Treatment Period.

Safety Population consisted of all randomized participants who received at least one dose of study drug.

Matching placebo tablet (5 mg and 10 mg), orally, once daily for 12 weeks.

UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment

ITT Population included all randomized participants. Data was summarized as per the treatment assigned.

Time to Absence of Bleeding on Treatment

Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment

Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12. The Baseline row shows the actual scores. The results at Week 12 are the difference in scores from Baseline to Week 12.

Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas	NCT02147158	Leiomyoma Uterine Hemorrh...	Ulipristal acet... Placebo	18 Years - 50 Years	Allergan
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas	NCT02147158	Leiomyoma Uterine Hemorrh...	Ulipristal acet... Placebo	18 Years - 50 Years	Allergan
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas	NCT02147158	Leiomyoma Uterine Hemorrh...	Ulipristal acet... Placebo	18 Years - 50 Years	Allergan
Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation	NCT02922127	Contraception	Ulipristal Acet... Combined Oral C...	18 Years - 39 Years	Columbia University
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas	NCT02147197	Leiomyoma Uterine Hemorrh...	Ulipristal acet... Placebo	18 Years - 50 Years	Allergan

Spots Global Cancer Trial Database for ulipristal acetate (upa)