PROCTOKINASE in acute pelvic inflammatory disease

Efficacy and safety of the PROCTOKINASA® suppository in the treatment of acute pelvic inflammatory disease in Primary Care

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000416

Enrollment

Registered

2023-02-09

Start date

2016-06-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic inflammatory disease

Interventions

Group 1: 200 mg PROCTOKINASE suppository rectally every 8 hours for 48 hours + schedule A or B. Group 2: 20 mg Piroxican suppository rectally every 8 hours for 48 hours + schedule A or B. Schedule A

Suppositories

Piroxicam

Administration, Rectal

Tetracycline

Metronidazole

Ciprofloxacin

Tablets

Administration, Oral

proctokinase

Eligibility

Sex/Gender

Female

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female patients with a clinical and ultrasound diagnosis of mild and moderate acute pelvic inflammatory disease who have signed the informed consent. 2. Patients over 18 years of age. 3. Patients who do not require hospitalization.

Exclusion criteria

Exclusion criteria: 1. Patients who are participating in another clinical trial. 2. Breastfeeding patients. 3. Patients with a history of hypersensitivity to the product or to any of the components of the formulation. 4. Female patients with a clinical and ultrasound diagnosis of severe PID or with criteria for hospitalization. 5. Patients with surgery for less than 7 days, active bleeding or previously diagnosed bleeding disorder. 6. Patients with a diagnosis of arterial hypertension.

Design outcomes

Primary

Measure	Time frame
Pain severity. Pain resolution time (pain analogue scale: Much better, Better, No change, Worse, Much worse). Measurement time: on the 3rd, 5th, 10th day and on the 15th day. Measurement time: on the 3rd, 5th, 10th day and on the 15th day.	—

Secondary

Measure	Time frame
Evolution of ultrasound findings (transvaginal ultrasound). Measurement time: baseline and after 5 days of treatment. Adverse Events-AE (Occurrence of any AE in the subject (yes/no); Description of the AE (Name of the adverse event); Duration of the AE (Difference in dates between the start and end of the event); Intensity of the AE (Mild , Moderate, Severe); AE severity (Serious/serious, Not serious/not serious); Attitude towards study treatment (no change, dose modification, temporary or permanent discontinuation of study treatment); AE outcome (recovered , improved, persists or sequelae); Causal relationship (1.Very Probable, 2.Probable, 3.Possible, 4.Improbable, 5.Not related, 6.Not evaluable)). Measurement time: up to 15 days of patient follow-up.	—

Measure

Time frame

Evolution of ultrasound findings (transvaginal ultrasound). Measurement time: baseline and after 5 days of treatment. Adverse Events-AE (Occurrence of any AE in the subject (yes/no); Description of the AE (Name of the adverse event); Duration of the AE (Difference in dates between the start and end of the event); Intensity of the AE (Mild , Moderate, Severe); AE severity (Serious/serious, Not serious/not serious); Attitude towards study treatment (no change, dose modification, temporary or permanent discontinuation of study treatment); AE outcome (recovered , improved, persists or sequelae); Causal relationship (1.Very Probable, 2.Probable, 3.Possible, 4.Improbable, 5.Not related, 6.Not evaluable)). Measurement time: up to 15 days of patient follow-up.

—

Countries

Cuba

Contacts

Public ContactMaria Marrero Miragaya

National Coordinating Center for Clinical Trials (CENCEC)

acelia@cencec.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026