Trial Outcomes & Findings for Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study (NCT NCT00958412)
NCT ID: NCT00958412
Last Updated: 2019-02-12
Results Overview
Number of participants who experienced 1 or more adverse event.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
6 months
Results posted on
2019-02-12
Participant Flow
Participant milestones
| Measure |
Proellex
Proellex: one (1) 25 mg capsule daily Study was terminated prematurely and no data is available
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Proellex
Proellex: one (1) 25 mg capsule daily Study was terminated prematurely and no data is available
|
|---|---|
|
Overall Study
Study prematurely terminated
|
18
|
Baseline Characteristics
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
Baseline characteristics by cohort
| Measure |
Proellex®
n=18 Participants
Proellex®: one (1) 25 mg capsule daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of participants who experienced 1 or more adverse event.
Outcome measures
| Measure |
Proellex®
n=18 Participants
Proellex®: one (1) 25 mg capsule daily
|
|---|---|
|
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
|
16 Participants
|
Adverse Events
Proellex®
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Proellex®
n=18 participants at risk
Proellex®: one (1) 25 mg capsule daily No data available
|
|---|---|
|
Immune system disorders
Seasonal Allergies
|
5.6%
1/18 • 6 months
|
|
Investigations
1.5 % decrease femur bone density
|
5.6%
1/18 • 6 months
|
|
Investigations
abnormal labs
|
5.6%
1/18 • 6 months
|
|
Reproductive system and breast disorders
cervical tenderness
|
5.6%
1/18 • 6 months
|
|
Nervous system disorders
Crying
|
5.6%
1/18 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystic Left Ovary
|
5.6%
1/18 • 6 months
|
|
Investigations
Decrease in Bone mineral Density
|
11.1%
2/18 • 6 months
|
|
Investigations
Decreased bone Mineral Density in the Lumbar Spine
|
11.1%
2/18 • 6 months
|
|
Reproductive system and breast disorders
Decreased Libido
|
5.6%
1/18 • 6 months
|
|
Investigations
Elevated ALT
|
5.6%
1/18 • 6 months
|
|
Investigations
Elevated AST
|
5.6%
1/18 • 6 months
|
|
Nervous system disorders
exacerbation migraine
|
5.6%
1/18 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
5.6%
1/18 • 6 months
|
|
Vascular disorders
Hot Flashes
|
22.2%
4/18 • 6 months
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • 6 months
|
|
Cardiac disorders
Irregular Heart Beat
|
5.6%
1/18 • 6 months
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
5.6%
1/18 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Cystic Ovary
|
5.6%
1/18 • 6 months
|
|
Investigations
Left hip bone mineral density decreased
|
5.6%
1/18 • 6 months
|
|
Gastrointestinal disorders
left lower quadrant pain
|
5.6%
1/18 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
left ovarian complex cyst
|
11.1%
2/18 • 6 months
|
|
Investigations
Lumbar Spine Bone Mineral Density Decreased
|
5.6%
1/18 • 6 months
|
|
Nervous system disorders
Mood Swings
|
11.1%
2/18 • 6 months
|
|
Gastrointestinal disorders
Right lower quadrant abdomen pain
|
5.6%
1/18 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right ovarian complex cyst
|
5.6%
1/18 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
right ovarian cyst 1.5cm
|
5.6%
1/18 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right Paraovarian cyst
|
5.6%
1/18 • 6 months
|
|
Infections and infestations
sinus infection
|
5.6%
1/18 • 6 months
|
|
Skin and subcutaneous tissue disorders
skin rash
|
5.6%
1/18 • 6 months
|
|
Reproductive system and breast disorders
vaginal discharge
|
5.6%
1/18 • 6 months
|
|
Infections and infestations
verruca vulgaris
|
5.6%
1/18 • 6 months
|
|
Investigations
weight gain
|
5.6%
1/18 • 6 months
|
|
Infections and infestations
Yeast Infection
|
5.6%
1/18 • 6 months
|
|
Reproductive system and breast disorders
sexual desire loss
|
5.6%
1/18 • 6 months
|
|
Psychiatric disorders
insomnia
|
5.6%
1/18 • 6 months
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER