Trial Outcomes & Findings for Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy (NCT NCT03671811)

Last Updated: 2026-01-06

Results Overview

Ki-67 represents a specific nuclear marker for cell proliferation that is measured by staining with specific antibodies by immunohistochemical (IHC) staining. The Ki-67 proliferation index is defined as percent tumor cells staining positive, and measured on a continuous scale of 0-100%, with higher values indicating higher proliferation. Ki-67 hotspot values were assessed at two time-points during this study, prior to treatment with megace +/- pterostilbene (pre-treatment), and following completion of treatment (post-treatment). Descriptive statistics were used to compare treatment-associated percent change in Ki-67 proliferation index between the 2 study arms, using a 1-sided test with significance at p \< 0.05.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Pre- and post-treatment up to 6 weeks

Results posted on

2026-01-06

Participant Flow

A total of 44 patients were accrued. Seven patients were not evaluable for various reasons: received \<10 days of study treatment (n = 5), disenrolled (n = 1), did not receive hysterectomy (n = 1). Consequently, 37 patients were randomized to treatment.

Participant milestones

Participant milestones
Measure	Arm I (Pterostilbene, Megestrol Acetate) Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Overall Study STARTED	23	21
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Pterostilbene, Megestrol Acetate) Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Overall Study Did not complete treatment (n=5), Disenrolled (n=1), Did not have hysterectomy (n=1)	4	3

Baseline Characteristics

Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=19 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=18 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO	Total n=37 Participants Total of all reporting groups
Age, Continuous	61.3 years n=37 Participants	63.9 years n=56 Participants	61.9 years n=82 Participants
Sex: Female, Male Female	19 Participants n=37 Participants	18 Participants n=56 Participants	37 Participants n=82 Participants
Sex: Female, Male Male	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=37 Participants	8 Participants n=56 Participants	16 Participants n=82 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=37 Participants	10 Participants n=56 Participants	21 Participants n=82 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	4 Participants n=56 Participants	4 Participants n=82 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	1 Participants n=56 Participants	1 Participants n=82 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants	2 Participants n=56 Participants	2 Participants n=82 Participants
Race (NIH/OMB) White	17 Participants n=37 Participants	10 Participants n=56 Participants	27 Participants n=82 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=37 Participants	1 Participants n=56 Participants	3 Participants n=82 Participants
Region of Enrollment United States	19 participants n=37 Participants	18 participants n=56 Participants	37 participants n=82 Participants

PRIMARY outcome

Timeframe: Pre- and post-treatment up to 6 weeks

Outcome measures

Outcome measures
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=19 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=18 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Tumor Ki-67 Proliferation Index	-26.7 percent change Standard Deviation 34.1	-25.7 percent change Standard Deviation 36.3

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: Only 36 patients had data for this endpoint.

These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). Gland cellularity will be assessed by counting the number of cells in one quarter of a high-power field (HPF) (average of 3 fields). The number of patients with an improvement in gland cellularity were compared between study arms.

Outcome measures

Outcome measures
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=19 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=17 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Histologic Response of Gland Cellularity	13 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: Only 36 patients had data for this endpoint.

These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The mitotic index will be calculated as the number of mitoses per HPF (average of 3 fields). The number of patients with an improvement in mitotic index were compared between study arms.

Outcome measures

Outcome measures
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=19 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=17 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Histologic Response of Mitotic Index	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: Only 36 patients had data for this endpoint.

These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The percentages of tumor that display squamous or mucinous metaplasia will be estimated as percentages, with \< 10% considered negative and \>= 10% as positive. The number of patients with an improvement in metaplasia were compared between study arms.

Outcome measures

Outcome measures
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=19 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=17 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Histologic Response of Metaplasia	8 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: Only 36 patients had data for this endpoint.

These histologic changes represent measures of growth and apoptosis, and will be separately scored in the pretreatment endometrial sample and the section of tumor from the hysterectomy (post-treatment sample). The number of patients with an improvement in eosinophilic metaplasia were compared between study arms.

Outcome measures

Outcome measures
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=19 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=17 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Histologic Response of Eosinophilic Metaplasia	9 Participants	5 Participants

SECONDARY outcome

Timeframe: Pre- and post-treatment up to 6 weeks

Population: Only 33 patients had data for this endpoint.

Immunohistochemistry stains with antibodies directed against Bcl-2 will be performed on pre- and post-treatment endometrial samples. Samples will be scored on a continuous scale (0-100%) using the product of the intensity of cytoplasmic staining, and the proportion of cells staining based on the distribution of staining. Descriptive statistics were used to compare the percent change in scores from pre-treatment to post-treatment between the 2 study arms.

Outcome measures

Outcome measures
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=16 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=17 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Immunohistochemical Expression of Bcl-2 to Assess Tumor Growth and Apoptosis	2.1 percent change Standard Deviation 5.2	1.2 percent change Standard Deviation 4.4

SECONDARY outcome

Timeframe: Pre- and post-treatment up to 6 weeks

Population: Only 25 patients had data for this endpoint.

Immunohistochemistry stains with antibodies directed against Casp3 to assess apoptosis will be performed on pre- and post-treatment endometrial samples. Samples will be scored by counting the number of positive staining nuclei per HPF. Descriptive statistics were used to compare the percent change in scores from pre-treatment to post-treatment between the 2 study arms.

Outcome measures

Outcome measures
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=13 Participants Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=12 Participants Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Immunohistochemical Expression of Casp3 to Assess Tumor Growth and Apoptosis	-46.4 percent change Standard Deviation 48.7	-8.8 percent change Standard Deviation 79.7

Adverse Events

Arm I (Pterostilbene, Megestrol Acetate)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Arm II (Megestrol Acetate)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 6262185265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Arm I (Pterostilbene, Megestrol Acetate) n=19 participants at risk Patients receive 100mg pterostilbene BID and 80mg megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO Pterostilbene: Given PO	Arm II (Megestrol Acetate) n=18 participants at risk Patients receive megestrol acetate PO BID for 3 weeks in the absence of disease progression or unaccepted toxicity. Megestrol Acetate: Given PO
Infections and infestations Upper respiratory infection	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	10.5% 2/19 • Number of events 2 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Investigations Cholesterol high	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Investigations Platelet count decreased	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Investigations Weight gain	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Investigations White blood cell decreased	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Metabolism and nutrition disorders increased appetite	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders cramps	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Nervous system disorders Dizziness	10.5% 2/19 • Number of events 2 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Nervous system disorders Headache	10.5% 2/19 • Number of events 2 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	16.7% 3/18 • Number of events 3 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Psychiatric disorders Agitation	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Renal and urinary disorders Urinary incontinence	10.5% 2/19 • Number of events 2 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Renal and urinary disorders Urinary tract pain	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Renal and urinary disorders Urinary urgency	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	11.1% 2/18 • Number of events 2 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Reproductive system and breast disorders Breast pain	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Reproductive system and breast disorders Pelvic pain	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal discharge	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal hemorrhage	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	22.2% 4/18 • Number of events 4 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Vascular disorders Hot flashes	0.00% 0/19 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	11.1% 2/18 • Number of events 2 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Vascular disorders Hypertension	5.3% 1/19 • Number of events 2 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	52.6% 10/19 • Number of events 10 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	15.8% 3/19 • Number of events 3 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
General disorders Chills	5.3% 1/19 • Number of events 1 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	0.00% 0/18 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.
General disorders Fatigue	26.3% 5/19 • Number of events 6 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.	22.2% 4/18 • Number of events 4 • Adverse events were assessed from the time of surgery until the 6-week post-suregry visit. "Other Adverse Events" include all events that were not severe adverse events, regardless of grade or relation to treatment.