Evaluation of the Contraceptive Efficacy

NCT06689150 | Completed DMC

• 1 other identifier: Hebatu Allah Mohamed
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Combined oral contraceptives are not the preparation of first choice in breastfeeding women as they may influence the quality and quantity of breast milk. In these cases, a progestogen-only pill is a suitable alternative, since progestogen-only pills contain no estrogen at all and a much lower dose of progestogen than do combined oral contraceptives Therefore, progestogen-only pills may also be more acceptable than combined oral contraceptives to women suffering from medical conditions that are associated with the use of combined oral contraceptives (e.g. nausea, headache and breast tension).

Conditions

Menstrual Bleeding, Heavy

Keywords

Drospirenon; Desogestrel; Levonorgestrel

Outcome Measures

Primary Outcomes (1)

• Irregular Vaginal Bleeding

  Efficacy of the different types of the progesterone only pills as : (Drosperinon tablets, Desogestrel tablets and Levonorgestrel tablets) which will be initiated on the first day of menstruation in controlling of irregular vaginal bleeding during menses

  9 Months

Study Arms (3)

Group A: Drospirenon (drospinetta)

ACTIVE COMPARATOR

About 100 women took Drospirenon (drospinetta) tab every day 24 and 4 placipo tablets for four days

Drug: Drospinetta

Group B: Desogestrel (Cirazette)

ACTIVE COMPARATOR

About 100 women took Desogestrel (Cirazette) tablet every day

Drug: Drospinetta

Group C: Levonorgestrel (Microlute)

ACTIVE COMPARATOR

About 100 women took Levonorgestrel (Microlute) tablet every day

Drug: Drospinetta

Interventions

Drospinetta DRUG

To evaluate the three different types of POPs, the new POPs Drosperinon 4 mg, Desogestrel 75 pg, and Levonorgestrel 30 pg in healthy female subjects as regard to the contraceptive efficacy, bleeding pattern, acceptability and safety

Also known as: Cirazette, Micrlute

Group A: Drospirenon (drospinetta); Group B: Desogestrel (Cirazette); Group C: Levonorgestrel (Microlute)

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 - 45 years.
• Non obese women with BMI between 18.5 : 29.9 kg/m2.
• Healthy women with good physical and mental health.
• Sexually active.
• Women have normal cycles (regular interval, duration, and amount of bleeding.
• Women willing to accurately fill in the diary card with daily information on vaginal bleeding and pill intake
• Women willing to give written informed consent.

You may not qualify if:

• obese medical history
• Contraindications to the use of progesterone only pills with medical eligibility criteria mec category 3 or 4: (malabsorptive procedures, current or history of ischemic heart disease, history of cerebrovascular accident, systemic lupus erythematosus, breast cancer, cirrhosis, liver tumors or antimicrobial therapy).
• Women with allergy from study medications.
• Women refusing to participate in the study.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University Hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Ahmed Ali Mohamed Nasr, M.D

  Al-Azhar University, Assuit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics & Gynecology

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 14, 2024
• Study Start: August 10, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 10, 2024
• Last Updated: November 14, 2024

Record last verified: 2023-08

Locations

EG (1)