The Safety of Proctofoam-HC in the Third Trimester of Pregnancy

• Sponsor: The Hospital for Sick Children (Other)
• Overall Status: Completed
• CT.gov ID: NCT00405288
• Collaborator: Duchesnay Inc. (Industry)
• Enrollment: 408
• Locations: 2
• Duration (Months): 43
• Patients Per Site: 204
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the fetal safety of topical application of Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids; Pregnancy	Drug: Proctofoam-HC®

Detailed Description

Hemorrhoids are a frequent condition in pregnancy. The rate is increased as pregnancy progresses, and they affect up to 24% of pregnant women in the third trimester. Complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with perianal irritation and itching, and in severe cases, severe pain and venous engorgement which could even lead to thrombosis and infarction. Hemorrhoids are treated with a variety of suppositories and gels, based on analgesic and anti-inflammatory effects. The safety of these antihemorrhoidal products has not yet been documented in pregnant women.

Proctofoam-HC® has been on the Canadian market for 25 years. It combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine HCl. It is approved for temporary relief of anorectal inflammation, pruritus, pain and swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and postoperative pain.

We hypothesize that local application of Proctofoam-HC® in the third trimester of pregnancy is safe for the mother and fetus.

Study Design

• Study Type: Observational
• Actual Enrollment: 408 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Proctofoam-HC® Women in the third trimester of pregnancy prescribed Proctofoam-HC® aerosol foam canister for 36 applications for treatment of symptoms of hemorrhoids. One applicatorful is to be applied into the anus (or on the perianal area) two or three times daily and after bowel evacuation.	Drug: Proctofoam-HC®; Observational study of the exposure to Proctofoam-HC®; Other Names: 1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®)
Control Control group of women in the third trimester of pregnancy who were not exposed to any teratogens during the course of the pregnancy, and to Proctofoam-HC any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.

Outcome Measures

Primary Outcome Measures

1. Birth-weight [until delivery]

   Weight of the baby measured in grams at time of birth.

Secondary Outcome Measures

1. Gestational Age at Delivery [until delivery]

   Fetal gestational age at delivery

2. Mode of Delivery [at birth]

   Method of delivery for both groups: vaginal or caesarean section

3. Prematurity [at birth]

   birth at <37 gestational weeks

4. Fetal Distress [at birth]

   Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid

5. Low Birth Weight at Birth [at birth]

   Low birth weight (birth weights <2500 grams)

6. Neonatal Health [at birth]

   Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• For intervention group, any pregnant woman with a primary anorectal condition during the third trimester of pregnancy

• For control group, women in third trimester of pregnancy not treated with Proctofoam, and matched on maternal age and smoking status

• for either group,no other pregnancy complications

Exclusion Criteria:

• exposure to known teratogens during pregnancy as evident either during the prenatal or postnatal interview

• insufficient English language skills to understand the questionnaires and assessment material

• Women who have received other corticosteroid medications (systemic or topical)during pregnancy

• Women with the following conditions: abscess, fistula, tuberculosis, varicella, acute Herpes Simplex or fungal infection

• age less than 18 years

• History of previous reaction to any of the product's components, such as: local irritation, hypertrichosis, hypopigmentation, etc.

• Known Intrauterine Growth Restriction (IUGR) or a chronic state that may cause IUGR (SLE, placental insufficiency).

• Multi fetal pregnancy

• Binge alcohol consumption (5 or more drinks on one occasion,in a row or within a short period of time)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5
2	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

• The Hospital for Sick Children
• Duchesnay Inc.

Investigators

• Principal Investigator: Gideon Koren, MD, The Hospital for Sick Children, Toronto Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gideon Koren, Chief, Global Child Health, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT00405288
• Other Study ID Numbers: 1000008482
• First Posted: Nov 30, 2006
• Last Update Posted: Feb 5, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Gideon Koren, Chief, Global Child Health, The Hospital for Sick Children: Hemorrhoids; Pregnancy; antihemorrhoidal; Proctofoam; infants
• Additional relevant MeSH terms: Hemorrhoids; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Pramoxine

Study Results

Participant Flow

Recruitment Details	In this multicentre study we recruited pregnant women who were prescribed Proctofoam-HC for hemorrhoids by their physicians and who completed two telephone interviews using two specially designed questionnaires.
Pre-assignment Detail	There were no significant events that occur before assignment of the enrolled patients to groups.

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Period Title: Overall Study
STARTED	204	204
COMPLETED	204	204
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Proctofoam-HC®	Control	Total
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.	Total of all reporting groups
Overall Participants	204	204	408
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	204 100%	204 100%	408 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (4.9)	31.5 (4.9)	31.75 (4.9)
Sex: Female, Male (Count of Participants)
Female	204 100%	204 100%	408 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	204 100%	204 100%	408 100%

Outcome Measures

1. Primary Outcome

Title	Birth-weight
Description	Weight of the baby measured in grams at time of birth.
Time Frame	until delivery

Outcome Measure Data

Analysis Population Description

Estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight at a power of 80% and alpha of 5%. Seven pairs of twin pregnancies were excluded from the comparison of birth weight.

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	201	201
Mean (Standard Deviation) [grams]	3406.9 (452.7)	3487.7 (491.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments	Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies. To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	50
	Confidence Interval	(2-Sided) 95%; 0 to 200
	Parameter Dispersion	Type: Standard Deviation; Value: 450
	Estimation Comments

2. Secondary Outcome

Title	Gestational Age at Delivery
Description	Fetal gestational age at delivery
Time Frame	until delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	204	194
Mean (Standard Deviation) [gestational weeks]	39.4 (1.4)	39.1 (2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; 0 to 3
	Parameter Dispersion	Type: Standard Deviation; Value: 3
	Estimation Comments

3. Secondary Outcome

Title	Mode of Delivery
Description	Method of delivery for both groups: vaginal or caesarean section
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	204	204
Vaginal delivery	173 84.8%	146 71.6%
Caesarean section	31 15.2%	55 27%
Unknown	0 0%	3 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments	The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	chi square
	Estimated Value	30
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Prematurity
Description	birth at <37 gestational weeks
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	201	190
yes	8 3.9%	10 4.9%
no	193 94.6%	180 88.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments	The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	chi square
	Estimated Value	5
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Fetal Distress
Description	Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	199	173
Fetal distress	36 17.6%	31 15.2%
No fetal distress	163 79.9%	142 69.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments	Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.97
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	chi square
	Estimated Value	10
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Low Birth Weight at Birth
Description	Low birth weight (birth weights <2500 grams)
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

Per protocol, the estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight (primary outcome) for a power of 80% and alpha of 5% was used.

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	200	201
Yes	6 2.9%	3 1.5%
No	194 95.1%	198 97.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments	Low birth weight <2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	binary
	Estimated Value	3
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Neonatal Health
Description	Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	199	199
Yes (present neonatal health concerns)	28 13.7%	24 11.8%
No (absent neonatal health concerns)	171 83.8%	154 75.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments	The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	chi square
	Estimated Value	10
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Post-Hoc Outcome

Title	Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth
Description	Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth
Time Frame	neonatal period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	199	179
Cardiovascular anomalies	2 1%	0 0%
Heart murmur	6 2.9%	4 2%
Premature atrial contraction	0 0%	2 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	proportion
	Estimated Value	4
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Post-Hoc Outcome

Title	Respiratory Neonatal Health Concerns
Time Frame	neonatal period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	199	178
Pulmonary aspiration	4 2%	0 0%
Mild asthma	2 1%	2 1%
Tachypnea	0 0%	2 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	proportion
	Estimated Value	3
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Post-Hoc Outcome

Title	Neonatal Health Concerns-infections
Description	Infections occuring in the neonatal period
Time Frame	neonatal period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	199	178
Urinary tract infections	2 1%	0 0%
Streptococcus B infection	0 0%	2 1%
Pneumonia	0 0%	2 1%
Leucocytosis	2 1%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.99
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	proportion
	Estimated Value	2
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Post-Hoc Outcome

Title	Skin Conditions in Neonatal Period
Time Frame	neonatal period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	199	178
Rash	2 1%	2 1%
Eczema	0 0%	2 1%
Acne	0 0%	2 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Proctofoam-HC®, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	proportions
	Estimated Value	2
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Post-Hoc Outcome

Title	Other Neonatal Health Concerns
Time Frame	neonatal period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proctofoam-HC®	Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.	Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
Measure Participants	199	178
Conjuctivitis	4 2%	0 0%
Myopia	0 0%	2 1%
Colic	0 0%	4 2%
Milk allergy	0 0%	2 1%
Hypoglycemia	4 2%	0 0%
Poor feeding	2 1%	0 0%
Poor weight gain	2 1%	2 1%
Anemia	0 0%	2 1%
Renal calculi	0 0%	2 1%

Adverse Events

Time Frame	The data was collected within the 4 year study period.
Arm/Group Title	Proctofoam-HC®		Control
Arm/Group Description	Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.		Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
All Cause Mortality
	Proctofoam-HC®		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Proctofoam-HC®		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/204 (0%)		0/204 (0%)
Other (Not Including Serious) Adverse Events
	Proctofoam-HC®		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/204 (0%)		0/204 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.