Comparison of The Effect of Implant and injectable contraceptive on Menstrual Pattern

Comparison of The Effect of Etonogestrel Subdermal Single Rod Implant and Depot Medroxyprogesterone Acetate on Menstrual Pattern: A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071211

Enrollment

Registered

2024-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Intervention1: Etonogestrel single rod subdermal implant: Women will receive Subdermal Implant insertion containing of 68 mg etonogestrel for 3 years. Menstrual pattern will be studied after 3 months

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing to participate in the study and for follow up at 3 months. 2. Age group of 18-40 years 3. Desire a highly effective temporary method of contraception

Exclusion criteria

Exclusion criteria: 1.Undiagnosed genital bleeding 2.Less than 6 weeks postpartum 3.Active thrombophlebitis or thromboembolic disease 4. Acute liver disease, benign or malignant liver tumors 5. Known or suspected breast cancer 6.Women with known case of depression or other mental Health disorder 7.On drugs induced by liver enzymes or drugs that interfere with coagulation 8.Severe cardiovascular disease 9.Severe hirsutism 10.Any skin infection at the local site of the proposed injection

Design outcomes

Primary

Measure	Time frame
Proportion of women with changed menstrual patterns (bleeding/spotting episodes, prolonged bleeding, frequent bleeding, infrequent bleeding, irregular bleeding and amenorrhea, as per FIGO criteria) at 3 months follow up in women initiated on Etonogestrel single rod Subdermal Implant and Depot-Medroxyprogesterone Acetate Injection.Timepoint: 3 months.	—

Secondary

Measure	Time frame
1.Proportion of women with side effects (pain at site of insertion/ injection, headache, dizziness, mood swings, weight gain, breast pain, abdominal pain, any other) in arm A and B assessed at 3 months of use. 2. Proportion of women very unsatisfied, unsatisfied, neutral, satisfied, very satisfied in arm A and B assessed at 3 months of use. 3. Proportion of women who chose to continue the current contraceptive method at 3 months of follow up in arm A and B. 4. Proportion of women who became pregnant during the use of the chosen method at 3 months of use in arm A and B. Timepoint: 3 months	—

Measure

Time frame

1.Proportion of women with side effects (pain at site of insertion/ injection, headache, dizziness, mood swings, weight gain, breast pain, abdominal pain, any other) in arm A and B assessed at 3 months of use. 2. Proportion of women very unsatisfied, unsatisfied, neutral, satisfied, very satisfied in arm A and B assessed at 3 months of use. 3. Proportion of women who chose to continue the current contraceptive method at 3 months of follow up in arm A and B. 4. Proportion of women who became pregnant during the use of the chosen method at 3 months of use in arm A and B. Timepoint: 3 months

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Countries

India

Contacts

Public ContactMeenakshi

Lady Hardinge medical college and Associated hospitals

drmeenakshisingh99@gmail.com9560511155

Outcome results